BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 14

    MDR report key: 12131440 · Received July 7, 2021

    Report

    Report Number
    9616656-2021-00780
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-25. H6: INVESTIGATION SUMMARY: TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES AND FOUR PHOTOS WERE RETURNED FROM LOT. NO. 0253605, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BENT NON PATIENT END OF CANNULA WAS OBSERVED ON BOTH SAMPLES. DUE TO THE CONDITION THE SAMPLES WERE RETURNED NO CLOG TEST COULD BE CARRIED OUT. 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. AS THE SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PEN NDL 32G 4MM PRO 14 NEEDLES WERE UNABLE TO PRIME OR THE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT THE DRUG DID NOT COME OUT WHEN PRIMING AND THE NEEDLE NPE WAS FOUND TO BE BROKEN.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER ZIP CODE : UNKNOWN. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD PEN NDL 32G 4MM PRO 14 NEEDLES WERE UNABLE TO PRIME OR THE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THAT THE DRUG DID NOT COME OUT WHEN PRIMING AND THE NEEDLE NPE WAS FOUND TO BE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027984 PEN NDL 32G 4MM PRO 14 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 0253605

    Patients

    Seq Age Sex Outcome Treatment
    1