MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-07 for HP TLC KIT 12 X 16CM CE 8888345629HP manufactured by Covidien.
[3711900]
It was reported to covidien on (b)(4). 2013 that a customer had an issue with hp tlc kit 12 x 16cm ce. The customer states that they attempted right femoral mahurkar line placement with ultrasound guidance. Pt was in the supine during insertion, no abnormal resistance or difficulty encountered with adequate return of venous blood visualized. Numerous attempts to remove the guide wire failed; unable to remove the guide wire. Catheter was removed, leaving the guide wire in. Visualized with c-arm, it appeared kinked. Pt was taken to interventional radiology for removal. No complications to the pt.
Patient Sequence No: 1, Text Type: D, B5
[11019662]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2013-00255 |
| MDR Report Key | 3301793 |
| Report Source | 06 |
| Date Received | 2013-08-07 |
| Date of Report | 2013-07-31 |
| Date of Event | 2013-07-05 |
| Report Date | 2013-07-31 |
| Date Mfgr Received | 2013-07-31 |
| Date Added to Maude | 2013-10-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE ROCK |
| 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 | HP TLC KIT 12 X 16CM CE |
| Generic Name | HP TLC KIT 12 X 16CM CE |
| Product Code | NKQ |
| Date Received | 2013-08-07 |
| Model Number | 8888345629HP |
| Catalog Number | 8888345629HP |
| Lot Number | UNK |
| 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 | 2013-08-07 |