BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8303198 · Received February 4, 2019

    Report

    Report Number
    1213809-2019-00152
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 13, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE SAFETYGLIDE NEEDLE IN AN OPENED PACKAGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH #7121694 (P/N 305902). ONE (1) SAMPLE WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. THE SHIELDED SAMPLE WAS RETURNED IN AN OPENED BLISTER PACK. THE SHIELD WAS REMOVED, AND THE NEEDLE WAS VISUALLY EXAMINED USING UNAIDED VISION. IT WAS OBSERVED THAT THERE IS FOREIGN MATTER (FM) ON THE NEEDLE. THE RETURNED SAMPLE WAS THEN EXAMINED USING 30X MAGNIFICATION AND IT WAS OBSERVED THAT THE FM ON THE NEEDLE IS NOT A GROWTH BUT RATHER IS PLASTIC SHAVINGS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THIS IS LIKELY FROM THE RESULT OF A NEEDLE SHIELD THAT WAS FOUND ON THE FLOOR AND ACCIDENTALLY PLACED IN WITH THE GOOD PARTS INSTEAD OF THE WASTE PARTS. THIS NEEDLE SHIELD THEN WAS SHIELDED ON A NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 49 BD SAFETYGLIDE¿ NEEDLES WERE NOTED TO CONTAIN FOREIGN MATTER CONTAMINATION PRIOR TO USE.

    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 49 BD SAFETYGLIDE¿ NEEDLES WERE NOTED TO CONTAIN FOREIGN MATTER CONTAMINATION PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94599 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7121694 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other