MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for MEDICHOICE BLOOD TRANSFER DEVICE BTD001 manufactured by Owens & Minor Distribution, Inc..
[136261278]
Malfunction of the medichoice blood transfer device with male luer lock lot# 1809dh01a. I have the used broken piece in my office for review if needed. Faulty transfer device used on patient. A piece of the transfer device broke off inside the extension set allowing blood to flow freely and all over the patient before i could clamp off the set and replace with a new extension set. I labeled the extension set with the broken piece from the transfer device and left it at the charge desk with wrapper from the transfer device. This is the second instance that this has happened in the last 2 weeks. Location: emergency department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8342870 |
| MDR Report Key | 8342870 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-14 |
| Date of Event | 2019-02-05 |
| Report Date | 2019-02-14 |
| Date Reported to FDA | 2019-02-14 |
| Date Reported to Mfgr | 2019-02-15 |
| Date Added to Maude | 2019-02-15 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICHOICE BLOOD TRANSFER DEVICE |
| Generic Name | SET, TRANSFER (BLOOD/PLASMA) |
| Product Code | KSB |
| Date Received | 2019-02-15 |
| Model Number | BTD001 |
| Catalog Number | BTD001 |
| Lot Number | 1809DH01A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC. |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |