MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for AVID MEDICAL / OWENS & MINOR CUSTOM PACK WILF013-31 manufactured by Avid Medical, Inc., A Medical Action Ind. Company 305.
[141187563]
Scrub tech opening the supplies for next procedure found particles on gown dry towel that came inside cataract pac. (b)(6) operating room #3 on (b)(6) 2019 at 0935hrs. No staff or pt injured. Psr number submitted. Certified scrub tech opened the pack, product sterile and sealed in manufactured packaging, expires on 08/01/2021, lot #1346856. Product should be free of foreign particles, clean and unstained. Similar incident on (b)(6) 2019 with the same type of custom pack. Pcc vendor for the (b)(6) notified, product turned over to ms (b)(6). Fda report will be submitted on 04/03/2019 hopefully due to email connectivity. Owens&minor, (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085614 |
| MDR Report Key | 8487377 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-02 |
| Date of Event | 2019-04-02 |
| Date Added to Maude | 2019-04-05 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | AVID MEDICAL / OWENS & MINOR |
| Generic Name | CATARACT CUSTOM PACK / EYE TRAY |
| Product Code | OJK |
| Date Received | 2019-04-04 |
| Returned To Mfg | 2019-04-02 |
| Model Number | CUSTOM PACK |
| Catalog Number | WILF013-31 |
| Lot Number | 1346856 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |