MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-01-07 for PALINDROME EMERALD UNK UNK DY manufactured by Covidien.
[1726463]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a hemodialysis catheter. The customer reports that they had a pt where the catheter fell out approx 4 weeks post insertion. The cuff was reportedly exposed and still attached to the catheter. Catheter had to be replaced with another.
Patient Sequence No: 1, Text Type: D, B5
[8960979]
Submit date: (b)(4) 2011. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2011-00009 |
| MDR Report Key | 1978097 |
| Report Source | 01,06 |
| Date Received | 2011-01-07 |
| Date of Report | 2010-12-17 |
| Report Date | 2010-12-17 |
| Date Reported to Mfgr | 2010-12-17 |
| Date Mfgr Received | 2010-12-17 |
| Date Added to Maude | 2011-02-14 |
| 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 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 | PALINDROME EMERALD |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2011-01-07 |
| Model Number | UNK |
| Catalog Number | UNK DY |
| Lot Number | 007110 |
| 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 | 2011-01-07 |