MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07 report with the FDA on 2013-10-21 for URINARY CATHETERS 02062339 manufactured by Convatec Inc.
[17930523]
It is reported that there are 'burrs' on the catheter tip.
Patient Sequence No: 1, Text Type: D, B5
[18076194]
This event as described is deemed a reportable malfunction. Add'l info indicates that 100 samples were rec'd and tested. Results show that 10 samples did not meet test requirements and that there were burrs at the catheter tip. Root cause analysis showed that the defect was due to incorrect adjustment of tip forming process of catheters. No pt was harmed as a result of this malfunction. No add'l info has been provided to date. Should add'l info becomes available, a f/u report will be submitted. Note: the actual date of event is unk, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2013-00039 |
| MDR Report Key | 3536156 |
| Report Source | 00,01,07 |
| Date Received | 2013-10-21 |
| Date of Report | 2013-09-23 |
| Date of Event | 2013-09-23 |
| Date Mfgr Received | 2013-09-23 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY SZARO, ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URINARY CATHETERS |
| Generic Name | UROLOGICAL CATHETER AND ACCESSORIES |
| Product Code | EXJ |
| Date Received | 2013-10-21 |
| Returned To Mfg | 2013-09-27 |
| Model Number | 02062339 |
| Catalog Number | 02062339 |
| Lot Number | 478335 |
| Device Expiration Date | 2018-07-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-21 |