BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL 21GA 1-1/4IN MX BUN

    MDR report key: 12316565 · Received August 12, 2021

    Report

    Report Number
    9614033-2021-00092
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    July 15, 2021
    Report Date
    November 24, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SAMPLE, PHOTO, AND VIDEO RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, A PERFORATION IN THE UPPER PART OF THE DAMAGE IS OBSERVED. FUNCTIONAL TESTING IS PERFORMED AND LEAKAGE IS OBSERVED DUE TO THE DAMAGE IN THE BARREL. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH MISALIGNMENT IN THE SILICONE DOSING DISC DUE TO DIFFERENCE IN THE SIZE OF THE CYLINDER DIAMETER WITH THE TRANSFER DISC. ACTION PLANS IN THE TRANSFER DIAL (ADJUSTMENT) BETWEEN SILICONE DIAL AND CYLINDER PLUG PISTON ASSEMBLY DIAL HAVE BEEN FOLLOWED TO AVOID RECURRENCE IN THE GENERATION OF THE FRACTURED BARREL DEFECT. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 40 SYRINGE 10ML LL 21GA 1-1/4IN MX BUN EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY FOUND IN ANOTHER HOSPITAL MORE SYRINGES LEAKING FROM LOT 1043594. THE SYRINGES WERE IN USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 40 SYRINGE 10ML LL 21GA 1-1/4IN MX BUN EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY FOUND IN ANOTHER HOSPITAL MORE SYRINGES LEAKING FROM LOT 1043594. THE SYRINGES WERE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212477 SYRINGE 10ML LL 21GA 1-1/4IN MX BUN SYRINGE FMF BECTON DICKINSON DE MEXICO 1043594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown