MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2017-03-06 for BD BONNANO? SUPRAPUBIC CATHETER TRAY 408289 manufactured by Bd Caribe Ltd..
[69184450]
Complete medical device brand name: bd bonnano? Suprapubic catheter tray: 14 g x 11 in. Fep polymer catheter, 18 g puncture needle, adapter clamp. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69184451]
It was reported that the patient was admitted for tapping of ascites. When the pigtail catheter in the bd bonnano? Suprapubic catheter tray was being inserted into the patient's abdomen, the catheter snapped off and the distal part was retained in the patient's abdomen. The surgical team attempted to retrieve the missing piece through the skin but was not successful. The patient finally went to the operating theater and had a laparoscopy, drainage of ascites, and retrieval of the retained catheter.
Patient Sequence No: 1, Text Type: D, B5
[77963093]
Results: one used sample was returned for evaluation. A visual inspection confirmed the customer's reported defect (catheter break/separation after placement). A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6144689. Conclusion: although the returned sample confirmed the customer's reported defect, an absolute root cause for this incident cannot be determined. Based on an evaluation of severity and frequency, no corrective action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2618282-2017-00002 |
| MDR Report Key | 6381873 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2017-03-06 |
| Date of Report | 2017-05-26 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-07 |
| Device Manufacturer Date | 2016-05-23 |
| Date Added to Maude | 2017-03-06 |
| 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 |
| 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 | 2017-03-06 |
| Catalog Number | 408289 |
| Lot Number | 6144689 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-06 |