MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-04-14 for BD BONNANO? SUPRAPUBIC CATHETER TRAY 408289 manufactured by Bd Caribe Ltd..
[42712520]
A sample is not available for evaluation. An evaluation of photos sent by the patient confirmed the indicated failure as they showed the issues that were raised. A review of the device history record could not be performed as a lot # was not provided for this incident. Conclusion: the investigation summary conducted by our quality engineer states the following: the photos are of catalog 408289 bonanno subrapubic bladder drainage catheter. The catheter is received as a raw material from (b)(4). Elongation testing is performed as part of incoming inspection on an instron. The material is so strong that it will just stretch and thin out before breaking. Pull testing is also performed during assembly process after hub to catheter assembly. The same thinning out condition on the catheter is seen. The quality of the photos do not let us determine the condition of the catheter where the breakage occurs. From the photos we can see a bend (which could have been caused during removal), the breakage point and in some areas the catheter looks flattened. A clearer photo of the catheter ends that broke may help to determine if the cut is made by a sharp object. It is important to note that if the catheter was inserted into the patient, the catheter could not have been previously damaged. To insert the catheter, the 18ga needle has to travel the distance of the catheter and it will not fit through the catheter if there is any skiving, bent or thin areas. For the catheter to break in that manner there has to have been some contact with a sharp object to create an incision. Something must have happened after the catheter was inserted and the 18ga needle removed. I exposed a catheter to twice the heat exposure as per normal process to see if the catheter would become brittle and break by pulling or bending it. This exercise did not cause any breakage to the catheter. There is no known root cause for this specific failure mode. In summary, as per the photos and notes from the email, the catheter appears to have been successfully inserted into the patient. The poor quality of the photos provided do not help in confirming the type of cut the catheter endured to have broken apart. The strength of the catheter material will not allow it to break apart without the intervention of an external source. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Based on the above a capa is not required at this time. A sample is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[42712521]
The following is a timeline of events reported by a patient (the initial reporter): on (b)(6) 2015 - a bd bonnano suprapubic catheter tray was used to surgically place a suprapubic catheter into a patient. The patient found the catheter to be at an odd angle as it did not lay flay against his abdomen. On (b)(6) 2015 - the patient had a post-surgical follow appointment with his doctor (dr. (b)(6)) and was informed that the catheter was bent. On (b)(6) 2015 - the patient noted urine and blood leaking from the catheter insertion site and attempted to contact dr. (b)(6). On (b)(6) 2015 - dr. (b)(6) contacted the patient and advised him follow up with a dr. (b)(6) at (b)(6) and an appointment was scheduled for (b)(6) 2015. On (b)(6) 2015 - the patient saw dr. (b)(6), but dr. (b)(6) declined to remove the catheter. At approximately 2:00 pm that day the patient felt a "crunch" in his abdomen but did not observe anything different than what was observed on (b)(6) 2015. On (b)(6) 2016 - the patient was evaluated in an emergency department where he received an x-ray that visualized a broken catheter. The patient was referred to a urologist (dr. (b)(6)) to have the broken catheter surgically removed. On (b)(6) 2015 - the patient was evaluated by dr. (b)(6), received a ct scan, had bloodwork done, and had surgery to remove the broken catheter.
Patient Sequence No: 1, Text Type: D, B5
[53623593]
Additional information: after submitting the initial mdr on 4/14/2016, bd was made aware on 5/9/2016 that the customer had submitted a voluntary medwatch # mw5061560. The information contained in the medwatch is as follows: physician surgically installed (b)(4) bonnano suprapubic catheter on (b)(6) 2015. Catheter bent up inside pt that date. Pt noted exterior mounting plate was at an odd angle (b)(6) 2015. Physician noted suprapubic catheter was bent and at an odd angle during office visit (b)(6) 2015. Urine leaking from beneath catheter securing plate (b)(6) 2015. Second phsician noted suprapubic catheter was bent during (b)(6) 2015 office visit. Interior suprapubic catheter snappedat one of the bends inside pt later in the day (b)(6) 2015. Attempted removeal of suprapubic catheter (b)(6) 2015, resulted in only 1 inch of catheterthat had been inside the pt, still attachjed to plate when exterior plate was lifted from the pt. Fractured-off remaining 7 inches of suprapubic catheter remained in pt's abdominal cavity and bladder. Pt went to er (b)(6) 2015where x-rays confirmed presence and location of fractured-off sp catheter. Surgery performed (b)(6) 2015, to remvefractured-off suprapubic catheter from pt's abdominal cavity and bladder.
Patient Sequence No: 1, Text Type: N, H10
[53623594]
Additional information received via medwatch # mw5061560: physician surgically installed (b)(4) bonnano suprapubic catheter on (b)(6) 2015. Catheter bent up inside pt that date. Pt noted exterior mounting plate was at an odd angle (b)(6) 2015. Physician noted suprapubic catheter was bent and at an odd angle during office visit (b)(6) 2015. Urine leaking from beneath catheter securing plate (b)(6) 2015. Second physician noted suprapubic catheter was bent during (b)(6) 2015 office visit. Interior suprapubic catheter snapped at one of the bends inside pt later in the day (b)(6) 2015. Attempted removal of suprapubic catheter (b)(6) 2015, resulted in only 1 inch of catheter that had been inside the pt, still attached to plate when exterior plate was lifted from the pt. Fractured-off remaining 7 inches of suprapubic catheter remained in pt's abdominal cavity and bladder. Pt went to er (b)(6) 2015 where x-rays confirmed presence and location of fractured-off sp catheter. Surgery performed (b)(6) 2015, to remove fractured-off suprapubic catheter from pt's abdominal cavity and bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2016-00003 |
| MDR Report Key | 5578700 |
| Report Source | OTHER |
| Date Received | 2016-04-14 |
| Date of Report | 2016-08-19 |
| Date of Event | 2016-03-12 |
| Date Mfgr Received | 2016-04-06 |
| Date Added to Maude | 2016-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BD CARIBE LTD. |
| Manufacturer Street | ROAD 31 K.M. 24.3 |
| Manufacturer City | JUNCOS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BONNANO? SUPRAPUBIC CATHETER TRAY |
| Generic Name | SUPRAPUBIC CATHETER TRAY |
| Product Code | FEZ |
| Date Received | 2016-04-14 |
| Catalog Number | 408289 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE LTD. |
| Manufacturer Address | ROAD 31 K.M. 24.3 JUNCOS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-14 |