MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-07-23 for DIALYSIS UNK UNK DY manufactured by Covidien.
[20105399]
It was reported to covidien on (b)(4) 2013 that a customer had an issue with a peritoneal dialysis catheter. The customer reports the pt underwent an elective surgical procedure (tummy tuck) and during this procedure, the surgeon had disrupted the catheter that was in place. He then placed the same catheter back into the pt, instead of a new one. On (b)(6) 2013, the pt experienced peritonitis due to a break in aseptic technique. The pt was not hospitalized for the peritonitis. A peritoneal effluent culture was performed and the result showed no growth. Treatment was not reported.
Patient Sequence No: 1, Text Type: D, B5
[20166996]
Submit date: (b)(4) 2013. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2013-00240 |
| MDR Report Key | 3252460 |
| Report Source | 08 |
| Date Received | 2013-07-23 |
| Date of Report | 2013-07-09 |
| Report Date | 2013-07-09 |
| Date Reported to Mfgr | 2013-07-09 |
| Date Mfgr Received | 2013-07-09 |
| Date Added to Maude | 2013-08-01 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| 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 | DIALYSIS UNK |
| Generic Name | DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2013-07-23 |
| Model Number | UNK DY |
| Catalog Number | UNK DY |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2013-07-23 |