MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for FILTERED EXTENSION SET 16IN FE2012F 473989 manufactured by B. Braun Medical, Inc..
[123489441]
After ocrevus finished infusing, and staff was taking it down, staff noted there was a puddle on the floor. On investigation, staff noted there was a leak from the iv tubing. Approximately 75- 100ml (about 120 mg) of medication had leaked onto the floor. Did receive remainder of infusion, approximately 150-170 ml or 180 mg. Provider aware, a leak in the filter extension set was noticed near the yellow port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080386 |
| MDR Report Key | 7938716 |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-02 |
| Date Added to Maude | 2018-10-05 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | FILTERED EXTENSION SET 16IN |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2018-10-04 |
| Model Number | FE2012F |
| Catalog Number | 473989 |
| Lot Number | 0061618776 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-04 |