BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19967764 · Received August 12, 2024

    Report

    Report Number
    1213809-2024-00536
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    April 24, 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). SUPPLEMENTAL MDR/CORRECTION - NEEDLE CLOGGED/BLOCKED. CORRECTION: FOLLOWING SUBMISSION OF INITIAL MDR, LOT NUMBER WAS NOT CORRECTLY REPORTED. SECTION D UPDATED TO REFLECT CORRECT INFORMATION. EVALUATION: 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. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257786 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown