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 2012-11-02 for PALINDROME EMERALD 23/40KIT VT 8888145044 manufactured by Covidien Lp, Formerly Registered As Kendall.
[2954772]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a dialysis catheter. The customer reports the catheter was inserted on (b)(6) 2012. The catheter cracked above the hub on (b)(6) 2012 and pulled and replaced on that same day.
Patient Sequence No: 1, Text Type: D, B5
[10330593]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2012-00273 |
| MDR Report Key | 2861155 |
| Report Source | 01,05,06 |
| Date Received | 2012-11-02 |
| Date of Report | 2012-10-29 |
| Date of Event | 2012-06-27 |
| Report Date | 2012-10-29 |
| Date Reported to Mfgr | 2012-10-29 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2012-12-21 |
| 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 LP, FORMERLY REGISTERED AS KENDALL |
| 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 | 2012-11-02 |
| Model Number | 8888145044 |
| Catalog Number | 8888145044 |
| Lot Number | 135002 |
| 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 LP, FORMERLY REGISTERED AS KENDALL |
| Manufacturer Address | 5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-02 |