MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-29 for * MTBC8008 manufactured by M-tech Medical, Inc.
[17955781]
Phlebotomist drew an inpatient with a syringe and used a transfer device to put the blood into the blur top tube. Once she removed the tube from the transfer device, the needle attached to the transfer device stayed in the top of the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3811976 |
| MDR Report Key | 3811976 |
| Date Received | 2014-04-29 |
| Date of Report | 2014-04-29 |
| Date of Event | 2014-04-28 |
| Report Date | 2014-04-29 |
| Date Reported to FDA | 2014-04-29 |
| Date Reported to Mfgr | 2014-05-15 |
| Date Added to Maude | 2014-05-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | CONTAINER, SPECIMEN |
| Product Code | NNI |
| Date Received | 2014-04-29 |
| Model Number | * |
| Catalog Number | MTBC8008 |
| Lot Number | 306140104A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | M-TECH MEDICAL, INC |
| Manufacturer Address | 2270 W. GARDEN OF THE GODS SUITE 101 COLORADO SPRINGS CO 80919 US 80919 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-29 |