BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL-

    MDR report key: 19625266 · Received June 27, 2024

    Report

    Report Number
    3003152976-2024-00385
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    June 25, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903059591
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION: ONE PHOTO AND TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE PACKAGE IS OBSERVED TORN, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2212051, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO DAMAGE OR OTHER ISSUES WERE OBSERVED WITHIN THE PACKAGING, ALL SAMPLES COULD BE SEPARATED WITHOUT ISSUE. DURING THE PACKAGING PROCESS, ONCE THE PACKAGE IS SEALED, LONGITUDINAL CUTTERS CUT THE DIFFERENT BLISTERS, CREATING A DOTTED LINE FOR SEPARATION. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT WITHOUT ISSUE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT LIKELY OCCURRED DURING THE PACKAGING PROCESS AS A RESULT OF AN ISSUE WITH THE BLADES THAT CUT THE PACKAGING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    PERFORATION OPENS, HOLE IN THE PACKAGING WHEN DID THE INCIDENT OCCUR? BEFORE USE. THE PACKAGING IS A BIT TORN. COULD IT BE THAT THERE WAS SOMETHING WITH THE PERFORATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752318 SYRINGE 10ML LL- SYRINGE, PISTON FMF BECTON DICKINSON 2212051 00382903059591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown