BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM

    MDR report key: 10659668 · Received October 9, 2020

    Report

    Report Number
    9616656-2020-01019
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 18, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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: 2020-10-23. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (29) OPEN 5MM, 30G AUTOSHIELD DUO SAMPLES FROM LOT # 9231938. CUSTOMER STATES THAT THERE IS NO INSULIN FLOW WHEN TAKING THE INJECTION AND SOMETIMES DURING PRIMING. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 25 OUT OF 29 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA. 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. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NON PATIENT END OF THE CANNULA). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 28 BD AUTOSHIELD DUO PEN NEEDLES 30GA 5MM WERE UNABLE TO INJECT INSULIN AND UNABLE OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION AND SOMETIMES PRIMING. 28 PEN NEEDLES AFFECTED. LOT: 9231938. CATALOG: 329515. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 28 BD AUTOSHIELD DUO PEN NEEDLES 30 GA 5 MM WERE UNABLE TO INJECT INSULIN AND UNABLE OR DIFFICULT TO PRIME DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION AND SOMETIMES PRIMING. 28 PEN NEEDLES AFFECTED, LOT: 9231938, CATALOG: 329515, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123930 BD AUTOSHIELD DUO PEN NEEDLE 30GA 5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 9231938 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other