MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-03-05 for ANGEL WING 23G BCS W/LUER ADPTR 8881225307 manufactured by Tyco Healthcare/kendall.
[20830122]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[20843146]
It was reported to tyco healthcare/kendall that a customer had a problem with an angel wing. The customer stated that the pathology nurse was taking blood from the patient and the angel wing plastic component fell off the needle leaving the entire needle still in the patients vein. The needle was able to be removed by hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2007-00005 |
| MDR Report Key | 845437 |
| Report Source | 06 |
| Date Received | 2007-03-05 |
| Date of Report | 2007-02-14 |
| Date of Event | 2007-02-09 |
| Date Reported to Mfgr | 2007-02-14 |
| Date Mfgr Received | 2007-02-14 |
| Date Added to Maude | 2007-05-09 |
| 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 23G BCS W/LUER ADPTR |
| Generic Name | ANGEL WING BLOOD COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2007-03-05 |
| Model Number | 8881225307 |
| Catalog Number | 8881225307 |
| Lot Number | 6265253 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 832576 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-03-05 |