MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-08 for MEDICHOICE BLOOD TRANSFER DEVICE BTD001 manufactured by Owens & Minor Distribution, Inc..
[74625235]
Patient Sequence No: 1, Text Type: N, H10
[74625236]
Staff was experiencing problems with the new medichoice blood transfer device. According to the nurse report, the staff has been reporting that the grey rubber sheath (vacuum tube side of the device) has been hard to penetrate while placing the collection tube during a blood draw. Additionally, a technician has reported that the grey rubber sheath came off the vacutainer needle and stayed in the sample tube after it was removed during a blood draw. In a second instance, the technician was drawing labs including blood cultures with the vacutainer. The rubber piece of the vacutainer became lodged in the rubber top of the blood culture bottle, exposing the needle in the vacutainer. This resulted in free flowing blood from the vacutainer; the hcp was exposed to blood on his clothes and shoes. This item was brought in as a substitute for a different manufacturer's product which is normally used. We have had no issues with this other manufacturer's product.
Patient Sequence No: 1, Text Type: D, B5
[75953834]
Patient Sequence No: 1, Text Type: N, H10
[75953835]
Staff was experiencing problems with the new medichoice blood transfer device. According to the nurse report, the staff has been reporting that the grey rubber sheath (vacuum tube side of the device) has been hard to penetrate while placing the collection tube during a blood draw. Additionally, a technician has reported that the grey rubber sheath came off the vacutainer needle and stayed in the sample tube after it was removed during a blood draw. In a second instance, the technician was drawing labs including blood cultures with the vacutainer. The rubber piece of the vacutainer became lodged in the rubber top of the blood culture bottle, exposing the needle in the vacutainer. This resulted in free flowing blood from the vacutainer; the hcp was exposed to blood on his clothes and shoes. This item was brought in as a substitute for a different manufacturer's product which is normally used. We have had no issues with this other manufacturer's product. Initial email response received from manufacturer's sales rep mentioned there was a design change, however no formal manufacturer response has been received at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6551095 |
| MDR Report Key | 6551095 |
| Date Received | 2017-05-08 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-04-17 |
| Report Date | 2017-04-19 |
| Date Reported to FDA | 2017-04-19 |
| Date Reported to Mfgr | 2017-04-19 |
| Date Added to Maude | 2017-05-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | BLOOD TRANSFER DEVICE |
| Product Code | KSB |
| Date Received | 2017-05-08 |
| Model Number | BTD001 |
| Catalog Number | BTD001 |
| Lot Number | 1610DH01A |
| Device Expiration Date | 2019-10-01 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-05-08 |