BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19967605 · Received August 12, 2024

    Report

    Report Number
    1213809-2024-00535
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    June 27, 2023
    Report Date
    October 2, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) NEEDLE CLOGGED/BLOCKED: NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2258504. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE.

    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#:REJN0116, 4033669, 3332983, 2258504 IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE 2 SEPARATE NEEDLES CLOGGED DURING DEPO ADMINISTRATION, NEEDLE COMPLETELY DETACHED FROM SAFETY DEVICE AFTER IMMUNIZATION ADMINISTRATION AND HAD TO BE MANUALLY REMOVED FROM PATIENT'S ARM, 2 SEPARATE NEEDLES CLOGGED DURING DEPO ADMINISTRATION, 2 NEEDLES CLOGGED DURING DEPO ADMINISTRATION AND NEEDLE CLOGGED DURING DEPO ADMINISTRATION. VERBATIM: ISSUE 1 - 2 SEPARATE NEEDLES CLOGGED DURING DEPO ADMINISTRATION ISSUE 2 - NEEDLE COMPLETELY DETACHED FROM SAFETY DEVICE AFTER IMMUNIZATION ADMINISTRATION AND HAD TO BE MANUALLY REMOVED FROM PATIENT'S ARM ISSUE 3 -2 SEPARATE NEEDLES CLOGGED DURING DEPO ADMINISTRATION ISSUE 4 - 2 NEEDLES CLOGGED DURING DEPO ADMINISTRATION ISSUE 5 -NEEDLE CLOGGED DURING DEPO ADMINISTRATION ITEM - 305916 LOT - REJN0116, 4033669, 3332983, 2258504.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485192 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 2258504 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown