BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE ALLERGY W/NDL RB

    MDR report key: 8197192 · Received December 26, 2018

    Report

    Report Number
    1920898-2018-00962
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    November 20, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055402
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1CC BD ALLERGY SYRINGES FROM LOT # 8143654. CUSTOMER STATES THAT THE NEEDLE COMING THROUGH THE SHIELD AND THERE WAS A NEEDLE PRICK OF AN UNUSED NEEDLE. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED THE CANNULA THROUGH THE SHIELD, EXPOSING THE CANNULA, WHICH COULD CAUSE A NEEDLE STICK. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8143654. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: MANUFACTURING PROCESS: NEEDLE WAS BENT DURING THE SHIELDING PROCESS AND WAS NOT DETECTED AT THE POINT INSPECT MACHINE, WHERE AN ELECTRICAL CURRENT IS PASSED OVER THE SHIELD AND EJECTS PARTS WHERE AN ARC IS DETECTED. ADDITIONALLY, NEEDLE THROUGH SHIELD WOULD HAVE HAD TO PASS THROUGH UNDETECTED BY THE CAMERA SYSTEM UTILIZED ON THE PRODUCTION LINE. BOTH SYSTEMS ARE CHALLENGED AT REGULAR INTERVALS DURING PRODUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE ALLERGY W/NDL RB HAD STERILITY BREACH BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037026 BD¿ SYRINGE ALLERGY W/NDL RB GENERAL-PURPOSE SYRINGE FMF BD MEDICAL - DIABETES CARE 8143654 30382903055402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other