MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for CONVERTORS SURGICAL GOWN 9545 manufactured by Cardinal Health 200, Llc.
[178135687]
Disposable sterile gown opened to find a dead insect inside the packaging. Our supply chain organization was aware of the recall for this code but only for specific lot numbers. They have pulled everything with the lot number that has a j in it. This device did not have a j in it therefore it was decided that it is usable inventory. We have not found any other items at this time at this facility; however, there is hearsay that there have been bugs, hair, chewing gum, and even a cigarette butt found in sterile cardinal products before. Since the gown was in its own sterile package there wasn't data to support that the other gowns in their sterile package were compromised. If anything else is found they will consider pulling the lot. The gown was sent down to our local central supply department. I went to the department and found it. It had been reported to our cardinal healthcare rep. He reportedly has entered an investigation report and i am waiting for that report number. We have asked him to pick up the packaging for their testing and follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681030 |
| MDR Report Key | 9681030 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Report Date | 2020-02-04 |
| Date Reported to FDA | 2020-02-04 |
| Date Reported to Mfgr | 2020-02-07 |
| Date Added to Maude | 2020-02-07 |
| 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 | RISK MANAGER |
| 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 | CONVERTORS SURGICAL GOWN |
| Generic Name | GOWN, SURGICAL |
| Product Code | FYA |
| Date Received | 2020-02-07 |
| Model Number | 9545 |
| Catalog Number | 9545 |
| Lot Number | 19FCQ001 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DR WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |