MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-02-14 for PALINDROME EMERALD 19/36KIT VT 8888145043 manufactured by Covidien.
[2438100]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a dialysis catheter. The customer reports a tear resulting in leakage was seen at the junction of the hub and the catheter. The catheter was placed on 05/06/2009 and pulled and replaced on (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[9712578]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2012-00042 |
| MDR Report Key | 2462079 |
| Report Source | 01,05,06 |
| Date Received | 2012-02-14 |
| Date of Report | 2012-02-08 |
| Date of Event | 2012-01-27 |
| Date Facility Aware | 2012-02-08 |
| Report Date | 2012-02-08 |
| Date Reported to Mfgr | 2012-02-08 |
| Date Mfgr Received | 2012-02-08 |
| Date Added to Maude | 2012-04-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| 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 | PALINDROME EMERALD 19/36KIT VT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2012-02-14 |
| Model Number | 8888145043 |
| Catalog Number | 8888145043 |
| Lot Number | 829110 |
| 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 | 2012-02-14 |