MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-10-11 for OZ TWH 99 DBC2 8888411009 manufactured by Covidien.
[2338673]
It was reported to covidien on (b)(6) 2011 that a customer had an issue with a peritoneal dialysis catheter. On (b)(6) 2011 after implantation of the catheter the doctor performed the usual evaluation of the position and if the catheter is working as expected. Xray taken and no flow could be detected from the lower part of the catheter. Catheter was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
[9374237]
An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2011-00254 |
| MDR Report Key | 2313280 |
| Report Source | 01,06 |
| Date Received | 2011-10-11 |
| Date of Report | 2011-09-12 |
| Report Date | 2011-09-12 |
| Date Reported to Mfgr | 2011-09-12 |
| Date Mfgr Received | 2011-09-12 |
| Date Added to Maude | 2012-02-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH SHAW, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 5439 STATE ROUTE 40 |
| Manufacturer City | ARGYLE NY 12809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OZ TWH 99 DBC2 |
| Generic Name | PERITONAL DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2011-10-11 |
| Model Number | 8888411009 |
| Catalog Number | 8888411009 |
| Lot Number | 921251 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-11 |