BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 20352703 · Received October 2, 2024

    Report

    Report Number
    1213809-2024-00687
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 12, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - NEEDLE PULLED OUT OF HUB 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 NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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#: UNKNOWN, (POTENTIAL LOT PROVIDED 3205770 OR 3121225). IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT NEEDLE BROKE OFF WHILE IN THE PATIENT ARM, WAS ABLE TO REMOVE THE NEEDLE. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. NEEDLE BROKE OFF WHILE IN THE PATIENT ARM, WAS ABLE TO REMOVE THE NEEDLE. REF: (B)(4), LOT: 3205770 3121225 NOT SURE WHICH ONE BROKE OFF. (B)(6), CUSTOMER WOULD LIKE REPLACEMENTS. ADDITIONAL INFORMATION PROVIDED: HOW WAS THE NEEDLE REMOVED? KATRINA PULLED IT OUT OFF THE PT. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO INJURY. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? ANY PICTURE OF THIS COMPLAINT? NONE - UNUSED SAMPLES AVAILABLE - [email protected]. PLEASE CONFIRM WHICH BATCH NUMBER BROKE OFF: 3205770 OR 3121225. UNKNOWN AND UNSURE, DATE OF EVENT: 09/12/2024. PLEASE CONFIRM WHETHER THERE WAS ANY PATIENT IMPACT. NONE, THIS HAPPENED AFTER PT RECEIVED VACCINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34766 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown