MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2018-05-02 for UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER ULCS-8-30 manufactured by Cook Inc.
[107169239]
(b)(4). Pma/510(k) #: k140085. This report includes information known at this time.? A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[107169240]
It was reported that when the surgeon opened the universa loop nephrostomy percutaneous drainage catheter set, the needle was missing and they didn't have another needle in stock as the other sets they had with the same lot number were also missing their needles. The puncture part of the procedure could not be carried out as a result. The patient was under general anesthesia. They had to cancel the case and to reschedule the patient later when they could get equipment from another hospital. The kit does not contain a puncture needle yet the listing of contents indicates a 18 g x 20 cm needle. Upon further investigation, it was discovered that the needle listed in the bill of materials was missing from the set. This account had a total of seven devices from the same lot number that were missing the needle. A section of the device did not remain inside the patient? S body. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01307 |
| MDR Report Key | 7481007 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-05-02 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-02-24 |
| Date Mfgr Received | 2018-05-29 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2018-05-02 |
| 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 | UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER |
| Generic Name | KOB CATHETER, SUPRAPUBIC (AND ACCESSORIES) |
| Product Code | KOB |
| Date Received | 2018-05-02 |
| Catalog Number | ULCS-8-30 |
| 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 | 2018-05-02 |