BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 12475556 · Received September 15, 2021

    Report

    Report Number
    1213809-2021-00637
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 18, 2021
    Report Date
    October 13, 2021
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. 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 6 SYRINGE 3ML LL 200 S/C HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE BOXES HAVE DIFFERENT PACKAGING AND THEY ARE TWO DIFFERENT SIZES WITH THE SAME REFERENCE NUMBER.".

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1104797, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-06-01. MEDICAL DEVICE LOT #: 1063213, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: 2021-03-04. MEDICAL DEVICE LOT #: 1043500, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: 2021-03-30. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 SYRINGE 3ML LL 200 S/C HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE MEDICAL PROFESSIONAL, THE BOXES HAVE DIFFERENT PACKAGING AND THEY ARE TWO DIFFERENT SIZES WITH THE SAME REFERENCE NUMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369930 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF 309657 SEE H.10. 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1