MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-07-18 for ANG WNG 23G BCS W/LUER ATR X50 8881225307 manufactured by Covidien.
[4951868]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a blood collection set. The customer states that during a blood draw, blood started to leak from the needle and tubing connection where the butterfly safety shield is located. At the end of the blood draw, the needle disconnected from tubing. The needle, where the leak occurred, detached from the tubing as the clinician was pulling it out of the pt's arm. The needle was sticking half way into the pt's arm and half out. It was sticking out enough that the clinician could pull it out of the pt's arm without incident.
Patient Sequence No: 1, Text Type: D, B5
[11950241]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2014-00043 |
| MDR Report Key | 4010054 |
| Report Source | 06,07 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-06-23 |
| Date Mfgr Received | 2014-06-23 |
| Date Added to Maude | 2014-08-26 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 A LA P, LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANG WNG 23G BCS W/LUER ATR X50 |
| Generic Name | BLOOD COLLECTION SET |
| Product Code | GJE |
| Date Received | 2014-07-18 |
| Model Number | 8881225307 |
| Catalog Number | 8881225307 |
| Lot Number | 132490198X |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD INSURGENTES LIBRIAMENTO TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-18 |