MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-02-15 for ULTRATHANE SUPRAPUBIC CATHETER SET N/A J-USCS-120025 manufactured by Cook Inc.
[67482166]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[67482167]
It was reported by the user facility that a patient underwent a suprapubic tube insertion procedure at 12 noon. While in recovery at the hospital, the patient had to be taken back to the operating room due to the catheter leaking. The attending physician replaced the catheter with another ultrathane suprapubic catheter set. It was observed that the leakage was coming from the white part of the tube located at the end where the arm locks down. The customer stated, it was suggested that the cut occurred upon removal. There were no unintended sections of the device that remained inside of the patient? S body, nor did the patient experience any adverse effects due to this occurrence. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00221 |
| MDR Report Key | 6331382 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-02-15 |
| Date of Report | 2018-01-22 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2018-01-15 |
| Device Manufacturer Date | 2014-07-03 |
| Date Added to Maude | 2017-02-15 |
| 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 | MR. LARRY POOL |
| 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 | ULTRATHANE SUPRAPUBIC CATHETER SET |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2017-02-15 |
| Model Number | N/A |
| Catalog Number | J-USCS-120025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-15 |