ARTHROGRAM TRAY
Received Jul 6, 2020 · Event occurred Jun 4, 2020
Report 1625685-2020-00059 · MDR key 10236902
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 (6/1 AND 6/4). I HAVE RECEIVED TWO REPORTS OF STERILE ARTHROGRAM TRAYS NOT BEING STERILE UPON OPENING.
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) AND (B)(6)). I HAVE RECEIVED TWO REPORTS OF STERILE ARTHROGRAM TRAYS NOT BEING STERILE UPON OPENING.
Additional Manufacturer Narrative
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-06-26. H6: INVESTIGATION SUMMARY: SAMPLE EVALUATIONS AND EVALUATION OF THE PICTURES PROVIDED CONFIRMED THE REPORTED FAILURE MODE WITH FOREIGN MATTER LOCATED IN/ON THE TRAYS. A DHR REVIEW OF ALL APPLICABLE MANUFACTURING RECORDS FOR THE LOT DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. ASSOCIATES ARE REQUIRED TO WEAR PROPER PPE TO MINIMIZE ANY TRANSFER OF DEBRIS FROM THE ASSOCIATE OR WORK AREA TO THE PRODUCT. A REVIEW OF THE MANUFACTURING PROCESS NOTED THIS PRODUCT CODE IS MANUALLY ASSEMBLED. BASED ON THE REPORTED FAILURE MODE, THE MOST LIKELY SOURCE FOR THIS COMPLAINT WAS IDENTIFIED AS INADVERTENT TRANSFER OF HAIR INTO THE TRAY DURING THE ASSEMBLY OF THE UNIT. THE INVESTIGATION DID NOTE THIS PRODUCT CODE IS ASSEMBLED IN A CONTROLLED MANUFACTURING ENVIRONMENT WITH SPECIFIC CONTROLS AND REQUIREMENTS TO MINIMIZE DEBRIS TRANSFER INTO A FINISHED GOOD ASSEMBLY.