MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for VISTEC 7317 manufactured by Cardinal Health 200, Llc.
[183707175]
Or reports that when opening raytec sponge packaging, one of the sponges was attached to the paper seal which attaches to the plastic container. Did not reach the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9840971 |
| MDR Report Key | 9840971 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-02 |
| Report Date | 2020-03-06 |
| Date Reported to FDA | 2020-03-06 |
| Date Reported to Mfgr | 2020-03-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | 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 | VISTEC |
| Generic Name | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE |
| Product Code | GDY |
| Date Received | 2020-03-17 |
| Model Number | 7317 |
| Catalog Number | 7317 |
| Lot Number | #19L074562 |
| 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 | 2020-03-17 |