BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20141084 · Received September 4, 2024

    Report

    Report Number
    1213809-2024-00607
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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) FOLLOW UP MDR FOR DEVICE EVALUATION. ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE SAMPLE HAS A 3/4" CRACK IN THE SCALE MARKINGS AREA OF THE BARREL EXTENDING FROM THE ZERO LINE DOWN BELOW TO THE 2ML GRADUATION LINE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE BARREL CRACKED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) AND CORRECTIVE ACTIONS DETERMINATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    MATERIAL: 309646, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD LUER-LOK BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: STEVENS REF#(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: PRODUCT PROBLEM REPORT, PRODUCT INFORMATION, PRODUCT CODE: 309646, PRODUCT DESCRIPTION: SYRINGE HYPO 5CC L/L BX/125 P36 , LOT/SERIAL #: UNKNOWN, EXPIRY DATE: UNKNOWN. PROBLEM INFORMATION: PRODUCT CONCERN TICKET NUMBER: PC-28272 DATE OF INCIDENT: 13-AUG-2024 CONCERN DESCRIPTION: DISPENSED PREFILLED NARCOTIC SYRINGE TO THE PT. PT REPORTING SYRINGE IS LEAKING AND UNABLE TO INJECT THE DOSE. SAME ASSESSED BY WRITER. HAIRLINE CRACK NOTED ON THE BARREL. OCCURRENCES: 1 EA. REPORTER INFORMATION: XXXX. SITE INFORMATION: XXX. SAMPLE INFORMATION: INCIDENT SAMPLES: 1 EA, REPRESENTATIVE SAMPLES: 0, NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833770 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown