MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-09-12 for STAMEY MALECOT SUPRAPUBIC CATHETER SET UNK manufactured by Cook, Inc..
[4783213]
Patient is a (b)(6) male with a history of recent bladder neck reconstruction on (b)(6) 2014. He was admitted on (b)(6) 2014 for endoscopic evaluation. He had some leakage from his midline incision. He was taken to the operating room on (b)(6) 2014 for removal of all tubes and drains that were placed on (b)(6). With the 12 french malecot catheter was removed, the tip was missing. A cystoscopy was done and the missing tip was not in the bladder. A small incision was made and an exploratory lap was performed to look for the tip between the bladder and abdominal wall. It could not be located. An x-ray was also taken which did not show the missing tip. It is not radiopaque. It is unknown if a section of the device remains inside the patient. It could not be located. The patient has required a cystoscopy, an exploratory lap and an x-ray due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[12336095]
(b)(4). Event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[63228320]
The complaint product was not returned for investigation. A review of the complaint history, documentation, drawing, instructions for use (ifu), manufacturing instructions (mi), quality control (qc) and trends was conducted. Part number is not given in the complaint description. However, we infer that it refers to the 0838xx family of silicone malecot catheters, as they are the only ones that fit the description. Material and tensils strength are verified by the supplier, and shown on the certificate of compliance. In addition, component specification 0838xx states "check to be free of debris, discoloration, flaking or peeling" at a 100% inspection. Without evaluating the actual product, it is not possible to determine the cause of this failure. Appropriate controls are in place to detect any potential failure point in the tip of the catheter. We will continue to monitor for similar complaints and have notified the appropriate personnel. Per the quality engineering risk assessment (qera), no additional action required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00434 |
| MDR Report Key | 4143409 |
| Report Source | 00 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-08-18 |
| Date of Event | 2014-08-04 |
| Date Facility Aware | 2014-08-04 |
| Report Date | 2014-08-18 |
| Date Reported to FDA | 2014-08-12 |
| Date Reported to Mfgr | 2014-08-12 |
| Date Mfgr Received | 2014-08-18 |
| Date Added to Maude | 2014-10-07 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, DIRECTOR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAMEY MALECOT SUPRAPUBIC CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2014-09-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-12 |