BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 20022777 · Received August 21, 2024

    Report

    Report Number
    1213809-2024-00571
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    August 2, 2024
    Report Date
    September 11, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 - 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 NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL#: 305902. BATCH#: 4082651. IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO ITEM: 305902 QUANTITY AFFECTED: 1 BX. SERIAL/LOT NUMBER: (B)(4). PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: 7/31 CST EMAILED IN STATING THAT THE NEEDLE CAME OUT OF THE HUB AND STAYED IN THE PATIENT THIGH, SAFETY SLIDE MALFUNCTION ADDITIONAL INFORMATION PROVIDED: THERE WASN¿T ANY SERIOUS INJURY TO THE PATIENT OR TO MYSELF. THE DATE OF THE INCIDENT WAS AROUND (B)(6) 2024.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2272354 BD SAFETY-LOK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4082651 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown