BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19967571 · Received August 12, 2024

    Report

    Report Number
    1213809-2024-00534
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 9, 2024
    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). FOLLOW UP MDR FOR DEVICE EVALUATION. TWENTY-SEVEN SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, CLOGGED NEEDLE WAS NOT CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 4033669. 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 BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. 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 COMPLETEY 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
    2462040 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4033669 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown