MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-21 for CARDINAL 4468 manufactured by Cardinal Health.
[1688370]
Or staff reported that upon opening a sterile scrub care preoperative skin prep tray, made for our facility by cardinal health, it was noted the kit contained a long, black, human hair inside. Obviously this is a sterility concern. The kit was not used for procedure. It was saved and is available for return to the manufacturer. ====================== health professional's impression======================obviously this is a sterility issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1885200 |
| MDR Report Key | 1885200 |
| Date Received | 2010-10-21 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-10-01 |
| Report Date | 2010-10-21 |
| Date Reported to FDA | 2010-10-21 |
| Date Added to Maude | 2010-10-28 |
| 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 | CARDINAL |
| Generic Name | SCRUB CARE PREOPERATIVE SKIN PREP TRAY - STERILE - SINGLE US |
| Product Code | OJU |
| Date Received | 2010-10-21 |
| Model Number | 4468 |
| Catalog Number | 4468 |
| Lot Number | NEXT IN BOX Y10H2832 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-21 |