BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8025195 · Received October 31, 2018

    Report

    Report Number
    1213809-2018-00752
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 12, 2018
    Report Date
    March 4, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THREE PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICTED AN UNSHIELDED SAFETYGLIDE NEEDLE. THE SAMPLE WAS IDENTIFIED TO BE FROM BATCH #8232567 (P/N 305916). THE CANNULA HAD A LONG CURLED FIBER LARGER THAN LEVEL 3 IN SIZE ATTACHED TO IT NEAR THE BEVEL. IT WAS NOT POSSIBLE TO IDENTIFY THE TYPE OF FIBER FROM THE PHOTO DUE TO A BRIGHT ILLUMINATION OF THE SAMPLE INTERFERING WITH THE PICTURE¿S FOCUS. THREE PHOTOS WERE PROVIDED, TWO OF THE PHOTOS SHOW THE PACKAGING AND ONE PHOTO SHOWS A NEEDLE ASSEMBLY WITH A STRING OF PLASTIC ON THE TIP OF THE NEEDLE. ROOT CAUSE: SAFETYGLIDE LINE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW OF THE FINISHED DEVICE AS WELL AS ALL CANNULA BATCHES SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE HAD SOME "FUZZ/LINT" ON IT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THAT THE BD SAFETYGLIDE¿ NEEDLE HAD SOME "FUZZ/LINT" ON IT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862963 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8232567 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other