BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23G 1-1/4IN TW

    MDR report key: 8135466 · Received December 5, 2018

    Report

    Report Number
    8041187-2018-00457
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 21, 2018
    Report Date
    January 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    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

    INVESTIGATION SUMMARY: ONE PHOTO WAS RETURNED FOR EVALUATION. WHITE SUBSTANCE WAS OBSERVED ON THE NEEDLE HUB AND CANNULA FROM THE RETURNED PHOTO. IT IS POSSIBLE THAT THE WHITE SUBSTANCE COULD BE EPOXY. NO DHR WAS PERFORMED AS THE BATCH NUMBER IS UNKNOWN. THE MANUFACTURING PROCESS WAS REVIEWED. THIS MAY HAVE OCCURRED WHEN THE PRODUCTION TECHNICIAN HAD MISSED OUT TO CLEAR THE EFFECTED RACK. FUTURE CONTROL IS TO UPDATE OF OJT FOR THE ASSEMBLY LINE TROUBLESHOOTING FOR EXCESSIVE EPOXY TO REMOVE THE FIRST RACK WHENEVER THERE IS A RESTART AFTER CANNULATION STATION STOPPAGE. THERE WAS NO QUALITY NOTIFICATION RAISED FOR SIMILAR NON-CONFORMANCE FOR THE PAST ONE YEAR. NO SAMPLE WAS RETURNED FOR INVESTIGATION TO CONFIRM THE NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE 23G 1-1/4IN TW HAD A WHITE SUBSTANCE STUCK TO THE NEEDLE.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (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 A NEEDLE 23G 1-1/4IN TW HAD A WHITE SUBSTANCE STUCK TO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972839 NEEDLE 23G 1-1/4IN TW SYRINGE WITH NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other