BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 9168742 · Received October 8, 2019

    Report

    Report Number
    9614033-2019-00253
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 20, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED FOR INVESTIGATION, IT SHOWS BROWN SPOTS ON THE PLUNGER WHICH DO NOT COME OFF, SO THEY ARE EMBEDDED ON THE MOLDED PART. POSSIBLE ROOT CAUSE, THIS DEFECT CAN BE GENERATED DURING THE MOLDING OF THE PLUNGER DUE TO THE DEGRADATION OF THE RESIN HAVING A BURNED OR DIRTY APPEARANCE. NO CORRECTIVE ACTION AT THIS TIME, THE NUMBER OF DEFECTS REPORTED BY THE CLIENT IS WITHIN THE ACCEPTANCE LEVEL. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITH INTERNAL DIRT.

    Additional Manufacturer Narrative · 1

    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 THE SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITH INTERNAL DIRT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959365 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 9015808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other