MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-03 for MAXIMUS BLOOD TRANSFER ASSEMBLY MBC6008 manufactured by Maximus (quality Brand Of Medegen).
[21089726]
When the phlebotomist went to remove the blood culture bottle from the device, the plastic needle sheath came off and stayed in the bottle, allowing blood to flow freely from the device. The phlebotomist had to physically remove the sheath from the blood culture bottle contaminating the blood culture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039402 |
| MDR Report Key | 4305569 |
| Date Received | 2014-12-03 |
| Date Added to Maude | 2014-12-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXIMUS BLOOD TRANSFER ASSEMBLY |
| Generic Name | BLOOD TRANSFER DEVICE |
| Product Code | LIO |
| Date Received | 2014-12-03 |
| Catalog Number | MBC6008 |
| Lot Number | 303140330 |
| Device Expiration Date | 2017-03-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAXIMUS (QUALITY BRAND OF MEDEGEN) |
| Manufacturer Address | ONTARIO CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-03 |