MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-08-04 for PALINDROME EMERALD 23/40KIT VT 8888145044 manufactured by Covidien.
[18583351]
It was reported to covidien on 07/27/2009 that customer had an issue with a dialysis catheter. Customer states that they had to replace the catheter because the adaptors were cracked.
Patient Sequence No: 1, Text Type: D, B5
[18698103]
(b) (4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2009-00176 |
| MDR Report Key | 1485640 |
| Report Source | 06 |
| Date Received | 2009-08-04 |
| Date of Report | 2009-07-27 |
| Date of Event | 2009-04-01 |
| Report Date | 2009-07-27 |
| Date Reported to Mfgr | 2009-07-27 |
| Date Mfgr Received | 2009-07-27 |
| Date Added to Maude | 2010-04-20 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| 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 23/40KIT VT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2009-08-04 |
| Model Number | 8888145044 |
| Catalog Number | 8888145044 |
| Lot Number | 829303 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2009-08-04 |