BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    MDR report key: 10221838 · Received July 1, 2020

    Report

    Report Number
    9616656-2020-00615
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: H.6. INVESTIGATION SUMMARY: AS PER MANUFACTURING, A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. A REVIEW OF RISK MANAGEMENT DOCUMENT 10000084266, REVISION 10, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (NANO PRO PEN NEEDLE: NEEDLE DAMAGED NPE) WAS CAPTURED AND ADDRESSED APPROPRIATELY. TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FIVE PHOTOS WERE RETURNED FROM LOT. NO. 9240215, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND IT WAS OBSERVED THAT ONE SAMPLE WAS BENT AT THE NON PATIENT END AND THE SECOND SAMPLES WAS BROKEN AT THE NON PATIENT END. INVESTIGATION CONCLUSION: VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND IT WAS OBSERVED THAT ONE SAMPLE WAS BENT AT THE NON PATIENT END AND THE SECOND SAMPLES WAS BROKEN AT THE NON PATIENT END. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE DESCRIPTION: AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX CANNULA WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS COMPLAINING THAT THE NEEDLE IS DEFORMED. THE PATIENT IS SAYING THAT HE/SHE DIDN¿T DAMAGE IT DURING HIS/HER MANUAL OPERATION. THE PATIENT IS ALSO COMPLAINING THAT THIS INCIDENT SOMETIMES OCCURS AFTER HE/SHE SWITCHED FROM ANOTHER PRODUCT TO PRO 6 MONTHS AGO.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: AS PER MANUFACTURING, A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), REVISION 10, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (NANO PRO PEN NEEDLE: NEEDLE DAMAGED NPE) WAS CAPTURED AND ADDRESSED APPROPRIATELY. FIVE PHOTOS OF TWO 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9240215, CAT. NO. 320559. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. INVESTIGATION CONCLUSION: VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON ONE SAMPLE AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON THE SECOND SAMPLE. ROOT CAUSE DESCRIPTION: AS THE SAMPLES IN THE RETURNED PHOTOS WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX CANNULA WAS DEFORMED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT IS COMPLAINING THAT THE NEEDLE IS DEFORMED. THE PATIENT IS SAYING THAT HE/SHE DIDN¿T DAMAGE IT DURING HIS/HER MANUAL OPERATION. THE PATIENT IS ALSO COMPLAINING THAT THIS INCIDENT SOMETIMES OCCURS AFTER HE/SHE SWITCHED FROM ANOTHER PRODUCT TO PRO 6 MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680369 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX PEN NEEDLE FMI BECTON DICKINSON AND CO. 9240215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other