MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-03-26 for ANGEL WING 23GX3 / 4X12IN TUBING 8881225190 manufactured by Tyco Healthcare/kendall.
[593388]
It was reported to tyco healthcare/kendall that a customer had a problem with an angel wing. The client is reporting that when drawing blood from a pt, the safety shield did not work, the needle remained in the pt arm and the nurse was left with the closed system in her hand; the pt suffered a hematoma. Compression of the vein and the needle was removed with a cotton swab.
Patient Sequence No: 1, Text Type: D, B5
[7922296]
An investigation is currently underway; upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2007-00008 |
| MDR Report Key | 834687 |
| Report Source | 06 |
| Date Received | 2007-03-26 |
| Date of Report | 2007-03-05 |
| Date of Event | 2007-02-19 |
| Date Reported to Mfgr | 2007-03-05 |
| Date Mfgr Received | 2007-03-05 |
| Date Added to Maude | 2007-04-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | FABRICA BLVD INSURGENTES |
| Manufacturer City | LA MESA, TIJUANA * * |
| Manufacturer Country | MX |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL WING 23GX3 / 4X12IN TUBING |
| Generic Name | ANGEL WING BLOOD COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2007-03-26 |
| Model Number | 8881225190 |
| Catalog Number | 8881225190 |
| Lot Number | 6188289 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 821999 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-26 |