MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for MONOJECT NEEDLELESS MED PREP CANNULA 8881540111 manufactured by Cardinal Health.
[183272101]
When item was opened from package, rn noted there was some sort of contamination to the device. It was discolored with sediment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9828913 |
| MDR Report Key | 9828913 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-02-24 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-13 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | MONOJECT NEEDLELESS MED PREP CANNULA |
| Generic Name | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2020-03-13 |
| Model Number | 8881540111 |
| Catalog Number | 8881540111 |
| Lot Number | 930840 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 777 WEST STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |