BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 12450025 · Received September 9, 2021

    Report

    Report Number
    9616656-2021-01122
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 30, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT # : 1048294 ¿ DEVICE EXPIRATION DATE : 03/31/2024 ¿ DEVICE MANUFACTURE DATE : 02/17/2021. LOT # : 1048288 ¿ DEVICE EXPIRATION DATE : 03/31/2024 ¿ DEVICE MANUFACTURE DATE : 02/17/2021. LOT # : 1048295 ¿ DEVICE EXPIRATION DATE : 03/31/2024 ¿ DEVICE MANUFACTURE DATE : 02/17/2021. LOT # : 1022919 ¿ DEVICE EXPIRATION DATE : 02/29/2024 ¿ DEVICE MANUFACTURE DATE : 01/22/2021. LOT # : 0020475 ¿ DEVICE EXPIRATION DATE : 02/28/2023 ¿ DEVICE MANUFACTURE DATE : 01/20/2020. INVESTIGATION SUMMARY : THIS COMPLAINT IS FOR 5 LOTS AS LISTED ABOVE AND REFERRED TO BELOW IN GLOBAL TERMS WHERE APPROPRIATE. EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR INABILITY TO DETACH AS INTENDED ON THE REPORTED LOT NUMBERS. A REVIEW OF THE COMPLAINT LOT HISTORY RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THESE LOTS. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE FOR LOT # 1048294 ONLY AND NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE FOR THE OTHER LOTS HENCE THE ROOT CAUSE IS UNDETERMINED. SAMPLES RETURNED - CUSTOMER RETURNED (91) SEALED 5MM, 30G AUTOSHIELD DUP SAMPLES FROM LOT # 1048294. CUSTOMER STATES THAT THE BACK END OF THE NEEDLE REMAINED IN THE PEN AFTER DISCONNECTION. THIRTY OUT OF 91 RETURNED SAMPLES WERE TESTED AND ALL WERE ABLE TO SECURELY ATTACH AND EASILY DETACH FROM A PEN WITHOUT ANY OBSERVED DEFECTS. THE ATTACHED PHOTO WAS ALSO EXAMINED AND EXHIBITED A CANNULA COMING OUT OF THE SEPTUM OF A PEN. IT IS DIFFICULT TO DETERMINE THE ORIGIN OF THIS CANNULA HENCE NOT THE POTENTIAL ROOT CAUSE ABLE TO BE DETERMINED FOR THIS ISSUE. SAMPLES RETURNED - CUSTOMER RETURNED (25) SEALED BD AUTOSHIELD DUO PEN NEEDLES FROM LOT# 1048288. THE CUSTOMER REPORTED NEEDLE DOES NOT DETACH AS INTENDED. ALL 25 RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR ATTACHMENT AND DETACHMENT USING A TEST PEN INJECTOR. ALL 25 PEN NEEDLES WERE ABLE TO ATTACH TO AND DETACH FROM THE TEST PEN INJECTOR PROPERLY. NO DEFECTS WERE OBSERVED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. SAMPLES RETURNED - CUSTOMER RETURNED (51) SEALED BD AUTOSHIELD DUO PEN NEEDLES FROM LOT# 1048295. THE CUSTOMER REPORTED NEEDLE DOES NOT DETACH AS INTENDED. 30 OUT OF THE 51 RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR ATTACHMENT AND DETACHMENT USING A TEST PEN INJECTOR. ALL 30 TESTED PEN NEEDLES WERE ABLE TO ATTACH TO AND DETACH FROM THE TEST PEN INJECTOR PROPERLY. NO DEFECTS WERE OBSERVED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. SAMPLES RETURNED - CUSTOMER RETURNED (79) SEALED 5MM, 30G AUTOSHIELD DUP SAMPLES FROM LOT # 1022919. CUSTOMER STATES THAT THE BACK END OF THE NEEDLE REMAINED IN THE PEN AFTER DISCONNECTION. THIRTY OUT OF 79 RETURNED SAMPLES WERE TESTED AND ALL WERE ABLE TO SECURELY ATTACH AND EASILY DETACH FROM A PEN WITHOUT ANY OBSERVED DEFECTS. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. SAMPLES RETURNED - CUSTOMER RETURNED (21) SEALED 5MM, 30G AUTOSHIELD DUO SAMPLES FROM LOT # 0020475. CUSTOMER STATES THAT THE BACK END OF THE NEEDLE REMAINED IN THE PEN AFTER DISCONNECTION. ALL RETURNED SAMPLES WERE TESTED AND ALL WERE ABLE TO SECURELY ATTACH AND EASILY DETACH FROM A PEN WITHOUT ANY OBSERVED DEFECTS. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. CAPA/SA - BASED ON THE ABOVE INVESTIGATION NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW FOR EACH OF THE BATCHES WAS CARRIED OUT. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BD PEN NEEDLE AUTOSHIELD DUO 30GX5MM HAD ATTACHMENT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : IT WAS REPORTED THAT THE BACK END OF THE NEEDLES OF AS DUO REMAINED IN THE PEN AFTER DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346232 PEN NEEDLE AUTOSHIELD DUO 30GX5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 329515 SEE H.10 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1