MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-23 for ANG WING 23GA BCS W/BC HLDR 8881225265 manufactured by Covidien.
[17146446]
It was reported to covidien in 2009, that a customer had an issue with a blood collection syringe. Customer reports needle detached after use and remained in pt's arm. No medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[17242858]
Submit date: 01/23/2009. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2009-00002 |
| MDR Report Key | 1352985 |
| Report Source | 06 |
| Date Received | 2009-01-23 |
| Date of Report | 2009-01-15 |
| Report Date | 2009-01-15 |
| Date Reported to Mfgr | 2009-01-15 |
| Date Mfgr Received | 2009-01-15 |
| Date Added to Maude | 2009-07-07 |
| 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 | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | FABRICA BLVD INSURGENTES |
| Manufacturer City | LA MESA, TIJUANA 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANG WING 23GA BCS W/BC HLDR |
| Generic Name | BLOOD COLLECTION SYRINGE |
| Product Code | GJE |
| Date Received | 2009-01-23 |
| Model Number | 8881225265 |
| Catalog Number | 8881225265 |
| Lot Number | 8235184 |
| 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 | FABRICA BLVD INSURGENTES TIJUANA 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-23 |