BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE SFTYGLD 25X1 RB

    MDR report key: 20403411 · Received October 8, 2024

    Report

    Report Number
    1213809-2024-00692
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Date of Event
    August 24, 2024
    Report Date
    October 16, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - SAFETY MECHANISM DIFFICULT TO ACTIVATE (SAFETYGLIDE). SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL #:305916 BATCH#:4143073 IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X1 RB SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAD A SAFETYGLIDE NEEDLE 25G X 1¿ REF # 305916, LOT # 4143073 THAT THE SAFETY WOULD NOT EXTEND AS IF THE ARMS WERE FUSED ON EITHER SIDE OF THE SAFETY HINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20226 BD NEEDLE SFTYGLD 25X1 RB PISTON SYRINGE FMI BECTON DICKINSON MEDICAL SYSTEMS 4143073 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown