MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-12-15 for ANGEL WNG ADPTER/HLDR - MALE 8881225216 manufactured by Tyco Healthcare/kendall.
[546290]
It was reported to tyco healthcare/kendall that, a customer had a problem with a angel wing blood collection holder. The customer stated that they attached the vacutainer to the iv and when they went to plug the blood tubes in, the hub portion separated from the needle, which left an exposed needle.
Patient Sequence No: 1, Text Type: D, B5
[8051993]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2006-00061 |
| MDR Report Key | 797286 |
| Report Source | 06 |
| Date Received | 2006-12-15 |
| Date of Report | 2006-11-29 |
| Date of Event | 2006-11-26 |
| Date Reported to Mfgr | 2006-11-29 |
| Date Mfgr Received | 2006-11-29 |
| Date Added to Maude | 2006-12-26 |
| 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 WNG ADPTER/HLDR - MALE |
| Generic Name | BLOOD COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2006-12-15 |
| Returned To Mfg | 2006-12-13 |
| Model Number | 8881225216 |
| Catalog Number | 8881225216 |
| Lot Number | UNK |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 784823 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Baseline Brand Name | MONOJECT |
| Baseline Generic Name | BLOOD COLLECTION SET |
| Baseline Model No | 8881225216 |
| Baseline Device Family | SAFETY BLOOD COLLECTION SETS AND ACCESSORIES |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K940961 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-15 |