MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-11-05 for ANGEL WNG 25GX3 / 4X12IN TUBING 8881225208 manufactured by Covidien.
[17346256]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a blood collection set. The customer reports that the needle became unattached from the hub when removing, leaving the needle in the pt arm. The customer reports the needle was pulled out with no medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[17355307]
Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion , the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2012-00024 |
| MDR Report Key | 2860483 |
| Report Source | 06,07 |
| Date Received | 2012-11-05 |
| Date of Report | 2012-10-08 |
| Date of Event | 2012-10-08 |
| Date Facility Aware | 2012-10-08 |
| Report Date | 2012-10-08 |
| Date Reported to Mfgr | 2012-10-08 |
| Date Mfgr Received | 2012-10-08 |
| Date Added to Maude | 2013-02-12 |
| 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 | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO |
| Manufacturer City | TIJUANA BC |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL WNG 25GX3 / 4X12IN TUBING |
| Generic Name | BLOOD COLLECTION SET |
| Product Code | GJE |
| Date Received | 2012-11-05 |
| Model Number | 8881225208 |
| Catalog Number | 8881225208 |
| Lot Number | 2016267 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LI... TIJUANA BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-05 |