MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-24 for AW TRANSFER SET FOR BACT ALERT 8881225241 manufactured by Tyco Healthcare/kendall.
[19262483]
It was reported to tyco healthcare/kendall that a customer had a problem with an angel wing transfer set. The customer stated that a nurse was using the female bact alert transfer device to transfer blood from a syringe into a blood tube. The nurse luer locked the syringe onto the device, but then could not remove or unscrew the syringe from the transfer device. He tried several times to do so and then ended up accidentally pulling the top part of the transfer device off the base and the back end of the needle remained attached to the syringe. As the needle came detached from the dome part of the device, he stuck himself with the needle in the other hand. The patient that the employee was working with, has hep c.
Patient Sequence No: 1, Text Type: D, B5
[19443432]
Per the customer, a sample will not be returned for investigation. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2006-00055 |
| MDR Report Key | 808881 |
| Report Source | 06 |
| Date Received | 2006-10-24 |
| Date of Report | 2006-10-16 |
| Date Reported to Mfgr | 2006-10-16 |
| Date Mfgr Received | 2006-10-16 |
| Date Added to Maude | 2007-01-29 |
| 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 | AW TRANSFER SET FOR BACT ALERT |
| Generic Name | ANGEL WING TRANSFER SET |
| Product Code | GJE |
| Date Received | 2006-10-24 |
| Model Number | 8881225241 |
| Catalog Number | 8881225241 |
| Lot Number | 6146219 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 796378 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Baseline Brand Name | AW TRANSFER SET FOR BACT ALERT |
| Baseline Generic Name | ANGEL WING TRANSFER SET |
| Baseline Model No | 8881225241 |
| Baseline Catalog No | 8881225241 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-24 |