MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-02-10 for OPEN-ENDED PERITONEAL CATHETER WITH SLITS, 120CM NL8501376 manufactured by Integra Neurosciences Pr.
[4396425]
It was reported that an open-ended peritoneal catheter with the slits had black "dirt" adhered at the tip of the catheter. The issue was found upon incoming inspection.
Patient Sequence No: 1, Text Type: D, B5
[11899216]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648988-2014-00006 |
| MDR Report Key | 3832322 |
| Report Source | 01,08 |
| Date Received | 2014-02-10 |
| Date of Report | 2014-01-14 |
| Date Mfgr Received | 2014-01-14 |
| Date Added to Maude | 2014-06-13 |
| 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 | LINDA SERENTINO |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Phone | 6099365560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPEN-ENDED PERITONEAL CATHETER WITH SLITS, 120CM |
| Generic Name | NA |
| Product Code | GBW |
| Date Received | 2014-02-10 |
| Catalog Number | NL8501376 |
| Lot Number | 1133816 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-10 |