MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for VISTEC 7317 manufactured by Cardinal Health, Inc..
[174297642]
Opened x-ray detectable sponges onto sterile surgical field. Discovered lint within sponges; lint was gray fluff approximately 2 cm x 0. 5 cm. Picture attached. Two potential issues existed if it was not discovered; questionable sterility of the sterile field or lint could become a unintentional foreign body within the patient upon discovery, the entire sterile surgical field was taken down and another sterile field reestablished. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9568740 |
| MDR Report Key | 9568740 |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-05 |
| Report Date | 2019-12-17 |
| Date Reported to FDA | 2019-12-17 |
| Date Reported to Mfgr | 2020-01-09 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | 7317 |
| Catalog Number | 7317 |
| Lot Number | 19J050962 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-09 |