BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD DUO SAFETY PEN NEEDLE

    MDR report key: 11533112 · Received March 20, 2021

    Report

    Report Number
    9616656-2021-00298
    Event Type
    Malfunction
    Date Received
    March 20, 2021
    Date of Event
    February 24, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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: 2021-03-18. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) OPEN, ACTIVATED BD AUTOSHIELD DUO SAMPLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT MEDICATION IS LEAKING OUT OF THE NEEDLE. ALL RETURNED SAMPLES WERE TESTED BY REMOVING THE SHIELD ON THE NON PATIENT END OF THE PEN NEEDLE AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. CUSTOMER STATES THAT MEDICATION IS NOT FLOWING PROPERLY. ALL RETURNED SAMPLES WERE TESTED BY REMOVING THE SHIELD ON THE NON PATIENT END OF THE PEN NEEDLE AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE EXPERIENCED A CASES OF LEAKAGE AND A CASE OF BEING UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER CALLED STATING THE MEDICATION IS NOT FLOWING PROPERLY IN THE AUTOSHIELD DUO NEEDLES. STATED THE MEDICATION IS LEAKING OUT OF THE NEEDLE AND NOT GOING INTO THE INJECTION SITE. SPOUSE STATED SHE HAS 5 BOXES THAT POSSIBLY ALL HAVE THE SAME LOT #. ONLY 1 BOX HAS BEEN OPENED SO FAR. LOT # 0020469. CAT # 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE EXPERIENCED A CASES OF LEAKAGE AND A CASE OF BEING UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOUSE OF CONSUMER CALLED STATING THE MEDICATION IS NOT FLOWING PROPERLY IN THE AUTOSHIELD DUO NEEDLES. STATED THE MEDICATION IS LEAKING OUT OF THE NEEDLE AND NOT GOING INTO THE INJECTION SITE. SPOUSE STATED SHE HAS 5 BOXES THAT POSSIBLY ALL HAVE THE SAME LOT #. ONLY 1 BOX HAS BEEN OPENED SO FAR. LOT # 0020469, CAT # 329515, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433129 BD AUTOSHIELD DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 0020469 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1