ARTHROGRAM TRAY
Received Jul 6, 2020 · Event occurred Jun 1, 2020
Report 1625685-2020-00058 · MDR key 10234260
Device
Generic name
Arthrogram Tray
Manufacturer
Carefusion, IncModel number
4325Catalog number
4325
Lot number
0001331662
Product problems
- Delivered as Unsterile Product
- Delivered as Unsterile Product
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT ARTHROGRAM TRAY HAD FOREIGN MATTER IN THE TRAY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 4325 BATCH, NO: 0001331662. IT WAS REPORTED THAT: DEBRIS FOUND IN STERILE ARTHROGRAM TRAYS ON TWO DIFFERENT INCIDENT DATES (B)(6). I HAVE RECEIVED TWO REPORTS OF STERILE ARTHROGRAM TRAYS NOT BEING STERILE UPON OPENING.