MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-24 for OR SCRUB BRUSH EXIDINE CHG 4% 4458A manufactured by Carefusion 2200, Inc..
[5016524]
A nurse from the cath lab was prepping for a cath procedure and pulled out a chg scrub brush. The nurse noticed a black stain on the scrub brush which resembles mold. The packaging was and is intact. The stain is visible through the plastic packaging. The whole box was pulled from the shelf and returned to the manufacturer. There are a total of 30 individually wrapped devices per box.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4253058 |
| MDR Report Key | 4253058 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-24 |
| Date of Event | 2014-10-24 |
| Report Date | 2014-10-24 |
| Date Reported to FDA | 2014-10-24 |
| Date Reported to Mfgr | 2014-11-15 |
| Date Added to Maude | 2014-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OR SCRUB BRUSH EXIDINE CHG 4% |
| Generic Name | BRUSH, SCRUB, OPERATING-ROOM |
| Product Code | GEC |
| Date Received | 2014-10-24 |
| Model Number | 4458A |
| Catalog Number | 4458A |
| Lot Number | 0000696917 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 N FAIRWAY DR VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-24 |