MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for BD E-Z SCRUB? PREOPERATIVE SURGICAL SCRUB BRUSHES 371603 manufactured by Becton Dickinson Infusion Therapy Systems Inc..
[107574400]
The initial reporter also notified the fda on 04/05/2018 via medwatch #5076355. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[107574401]
It was reported that foreign matter described as? Dark, smelly, mold like substance? Was found on a bd e-z scrub? Preoperative surgical scrub brush. The brush was not used and there was no report of injury or medical interventions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1710034-2018-00214 |
| MDR Report Key | 7484621 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-14 |
| Date of Event | 2018-04-04 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2017-10-23 |
| Date Added to Maude | 2018-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD E-Z SCRUB? PREOPERATIVE SURGICAL SCRUB BRUSHES |
| Generic Name | DISPOSABLE SCRUB BRUSH |
| Product Code | GEC |
| Date Received | 2018-05-03 |
| Returned To Mfg | 2018-04-16 |
| Catalog Number | 371603 |
| Lot Number | 7283595 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
| Manufacturer Address | 9450 SOUTH STATE STREET SANDY UT 84070 US 84070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-03 |