BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23G 1-1/4IN TW

    MDR report key: 8880058 · Received August 9, 2019

    Report

    Report Number
    8041187-2019-00620
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 25, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TOTAL 118 ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION. 55 SAMPLES FROM BATCH 6081498, 9 SAMPLES FROM BATCH 6327491, 2 SAMPLES FROM BATCH 3241337, 5 SAMPLES FROM BATCH 6047363, 12 SAMPLES FROM BATCH 7139356, 6 SAMPLES FROM BATCH 1258442, 1 SAMPLE FROM BATCH 3357306, 2 SAMPLES FROM BATCH 4079352, 1 SAMPLE FROM BATCH 3080082, 1 SAMPLE FROM BATCH 5038037, 5 SAMPLES FROM BATCH 5259280, 2 SAMPLES FROM BATCH 7015402, 1 SAMPLE FROM BATCH 4303395, 2 SAMPLES FROM BATCH 6327491, 6 SAMPLES FROM BATCH 6169035, 1 SAMPLE FROM BATCH 6232023, 1 SAMPLE FROM BATCH 5323260, 6 SAMPLES WITH BATCH NUMBER NOT READABLE. ALL 118 REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR ILLEGIBLE LOT PRINT ON UNIT PACKAGE. 6 OUT OF 118 SAMPLES FAILED VISUAL INSPECTION FOR ILLEGIBLE LOT PRINT ON UNIT PACKAGE. THE MANUFACTURING PROCESS WAS REVIEWED. CURRENT CONTROL THERE IS A 3HOURLY OUTGOING INSPECTION AND 1HOURLY IN PROCESS INSPECTION TO CHECK FOR ILLEGIBLE PRINT ON UNIT PACKAGE. PROBABLE CAUSE COULD BE DUE TO THE INK ROLLER OUT OF INK DUE TO LONG PRODUCTION RUN. THE PRODUCTION TECHNICIANS WERE SUPPOSED TO CHANGE THE INK ROLLER WHEN DETECTED OUT OF INK OR DURING INSPECTION BUT COULD HAVE FAILED TO NOTICE THE INK ROLLER RUNNING OUT OF INK AND REPLACE IT ON TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE NEEDLE 23G 1-1/4IN TW HAS BEEN FOUND EXPERIENCING 50 OCCURRENCES OF LABEL ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: UNABLE TO READ LOT NUMBER OR EXPIRY DATE AS PRINT TOO FAINT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE NEEDLE 23G 1-1/4IN TW HAS BEEN FOUND EXPERIENCING 50 OCCURRENCES OF LABEL ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: UNABLE TO READ LOT NUMBER OR EXPIRY DATE AS PRINT TOO FAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675469 NEEDLE 23G 1-1/4IN TW SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other