BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 8348582 · Received February 18, 2019

    Report

    Report Number
    9616656-2019-00165
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 31, 2019
    Report Date
    April 1, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) OPEN AUTOSHIELD DUO SAMPLE WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT WHEN PRIMING, IT DID NOT PRIME, THE NEEDLE WAS BENT, AND THE CASING CAME OFF AND LEFT THE NEEDLE EXPOSED. THE SAMPLE WAS RETURNED WITH THE NON-PATIENT SHIELD SEPARATED FROM THE REST OF THE PEN NEEDLE. THE RETURNED SAMPLE WAS EXAMINED AND NO BENT CANNULA WAS OBSERVED. THE SAMPLE WAS ALSO TESTED AND WAS ABLE TO EXPEL PROPERLY. ONE OPEN 30G X 5MM SAFETY PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 8241613, CAT. NO. 329515. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE NON PATIENT END SHIELD WAS INCORRECTLY ASSEMBLED. DUE TO THE CONDITION THE SAMPLE WAS RETURNED NO CLOG TESTING COULD BE CARRIED OUT. NO ISSUES WERE OBSERVED WITH 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SEPARATED NP SHIELD). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA, CLOGGED CANNULA). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME. THE ROOT CAUSE OF THIS ISSUE IS THE ROTATION OF THE NON PATIENT SHIELD LOCKING INTO THE HUB NOT BEING SET CORRECTLY. CAPA 478527 WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE THERE WAS AN ISSUE WITH THE NEEDLE BEING BENT AND WHEN IT WAS TRYING TO BE REMOVED THE CASING CAME OFF LEAVING THE NEEDLE EXPOSED.

    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 WITH THE USE OF THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE THERE WAS AN ISSUE WITH THE NEEDLE BEING BENT AND WHEN IT WAS TRYING TO BE REMOVED THE CASING CAME OFF LEAVING THE NEEDLE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139939 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8241613 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other