MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-03-19 for AW BCS 23X7X3/4 W/LUER 8881225707 manufactured by Tyco Healthcare/kendall.
[809550]
It was reported to tyco healthcare/kendall in 2008 that a customer had an issue with an angel wing. The customer stated that the needle detached from the hub when the device was removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
[7954344]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2008-00006 |
| MDR Report Key | 1017407 |
| Report Source | 06 |
| Date Received | 2008-03-19 |
| Date of Report | 2008-02-26 |
| Date of Event | 2008-02-01 |
| Report Date | 2008-02-26 |
| Date Reported to Mfgr | 2008-02-26 |
| Date Mfgr Received | 2008-02-26 |
| Date Added to Maude | 2008-06-20 |
| 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 | 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 LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AW BCS 23X7X3/4 W/LUER |
| Generic Name | ANGEL WING BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2008-03-19 |
| Model Number | 8881225707 |
| Catalog Number | 8881225707 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1015407 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-19 |