MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for BD E-Z SCRUB 160 371603 manufactured by Becton Dickinson And Company.
[104714272]
In pharmacy iv cleanroom a bd e-z scrub 160 brush was opened to assist in handwashing. It was noted by iv technician that the scrub brush contained a dark, smelly substance on one part of the scrubber surface. Technician removed scrubber from area and restarted processes with a new scrubber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076355 |
| MDR Report Key | 7402263 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-04-04 |
| Date Added to Maude | 2018-04-06 |
| 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 | PHARMACIST |
| 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 | BD E-Z SCRUB 160 |
| Generic Name | BRUSH, SCRUB, OPERATING ROOM |
| Product Code | GEC |
| Date Received | 2018-04-05 |
| Model Number | 371603 |
| Lot Number | 7283595 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND COMPANY |
| Manufacturer Address | FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |