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.
[546288]
It was reported to tyco healthcare/kendall that a customer had a problem with a blood collection holder. The customer stated that the "cup" portion of the hub broke and a nurse rec'd a contaminated needle stick.
Patient Sequence No: 1, Text Type: D, B5
[7943532]
Per the customer, the sample will not be returned for evaluation. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2006-00060 |
| MDR Report Key | 797280 |
| 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 | US |
| 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 |
| Model Number | 8881225216 |
| Catalog Number | 8881225216 |
| Lot Number | UNK |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 784817 |
| 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 |