BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8692987 · Received June 12, 2019

    Report

    Report Number
    9614033-2019-00162
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 18, 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: PHOTOGRAPH AND PHYSICAL SAMPLE ARE RECEIVED FOR INVESTIGATION. UPON EVALUATION, A SYRINGE WITH MULTIPLE UNITS IN A PACKAGE (ASSEMBLED NEEDLES) ARE OBSERVED. 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. THE DEFECT CAN BE GENERATED DURING MANUFACTURING BY FAILURE IN THE ASSEMBLED NEEDLE FEEDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DAMAGE OCCURRED WITH A SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DOUBLE NEEDLE EXPOSED." 574 OCCURRENCES REPORTED BEFORE USE.

    Additional Manufacturer Narrative · 1

    (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 DAMAGE OCCURRED WITH A SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DOUBLE NEEDLE EXPOSED." 574 OCCURRENCES REPORTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484294 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 9015772

    Patients

    Seq Age Sex Outcome Treatment
    1 Other