BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8366274 · Received February 25, 2019

    Report

    Report Number
    1213809-2019-00269
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 22, 2019
    Report Date
    April 18, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE SAFETYGLIDE NEEDLES IN FULLY SEALED BLISTER PACKS CONFIRMED TO BE FROM BATCH #5001543 (P/N 305916) WERE RECEIVED AND EVALUATED. NO VISUAL DEFECTS WERE OBSERVED THROUGH THE PACKAGING. FURTHERMORE, 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. A LEAKAGE TEST WAS PERFORMED USING A FORCE GAGE AND TORQUE WRENCH. NO DEFECTS WERE OBSERVED. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE PRODUCT DEFECT WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161948 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 5001542 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other