BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 8875371 · Received August 8, 2019

    Report

    Report Number
    9616656-2019-00724
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    March 16, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) USED 30G X 5MM, BD AUTOSHIELD DUO PEN NEEDLE. CONSUMER REPORTED WHEN ADMINISTERING INSULIN INJECTION, THE SAFETY DID NOT FULLY ENGAGE AND BENT OVER. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THE NON-PATIENT END (NPE) CANNULA WAS BENT, THUS PREVENTING THE NPE CANNULA SAFETY-SHIELD MECHANISM FROM PROPERLY ACTIVATING. IT WAS ALSO OBSERVED THAT THE PATIENT END (PE) CANNULA SAFETY-SHIELD MECHANISM HAD PROPERLY ACTIVATED. SINCE THE SAMPLE WAS RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULA IS USER ERROR WHEN ATTACHING THE PEN NEEDLE TO A PEN INJECTOR. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM EXPERIENCED SAFETY SHIELD FAILURE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329505 BATCH NO: 8241576 VERBATIM: WHEN ADMINISTERING INSULIN INJECTION, THE SAFETY DID NOT FULLY ENGAGE AND BENT OVER. NO DIFFICULTY WITH INJECTION THAT WOULD HAVE BENT THE NEEDLE ON INSERTION OR REMOVAL.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, 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 AN UNSPECIFIED NUMBER OF PEN NEEDLE AUTOSHIELD DUO 30GX5MM EXPERIENCED SAFETY SHIELD FAILURE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329505, BATCH NO: 8241576. VERBATIM: WHEN ADMINISTERING INSULIN INJECTION, THE SAFETY DID NOT FULLY ENGAGE AND BENT OVER. NO DIFFICULTY WITH INJECTION THAT WOULD HAVE BENT THE NEEDLE ON INSERTION OR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671146 PEN NEEDLE AUTOSHIELD DUO 30GX5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. 8241576

    Patients

    Seq Age Sex Outcome Treatment
    1 Other