MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for VISTEC 7317 manufactured by Cardinal Health 200, Llc.
[185223447]
From staff: a bug/worm/? Was found in a sterile surgical sponge while setting up for a case. Prior to bringing the patient into the room the surgical technician that was setting up the table noticed the bug. Sterile processing department was notified, and the table was torn down and new supplies were ordered from the sterile core. The sponges and packaging were given to the sterile processing department. The contaminated supplies/instruments were removed from the room. Once the new supplies arrived the table was set back up. Manufacturer response for vistec x-ray detectable gauze sponge, vistec x-ray detectable gauze sponge (per site reporter). Response was that they will help coordinate next steps with the product, quality and manufacturing teams.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888415 |
| MDR Report Key | 9888415 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-02 |
| Report Date | 2020-03-16 |
| Date Reported to FDA | 2020-03-16 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| 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 | 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 | VISTEC |
| Generic Name | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
| Product Code | GDY |
| Date Received | 2020-03-27 |
| Model Number | 7317 |
| Catalog Number | 7317 |
| Lot Number | 18E067862 OR 19K169062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |