BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 19G 1-1/2IN TW

    MDR report key: 9982585 · Received April 21, 2020

    Report

    Report Number
    8041187-2020-00218
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 6, 2020
    Report Date
    June 9, 2020
    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
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/19/2020 . H.6. INVESTIGATION: TWO PHOTOS AND TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION IT WAS OBSERVED THAT THE SAMPLE FOR BATCH 9143556 HAD BLACK FOREIGN MATTER ON THE HUB SCRUFF ON THE NEEDLE HUB COLLAR AND THE SAMPLE FOR BATCH 9108849 HAD BLACK EMBEDDED FOREIGN MATTER PARTICLES ON THE NEEDLE HUB. THE INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE SAMPLE WITH EMBEDDED BLACK FOREIGN MATTER PARTICLES WAS SENT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS. THE FTIR RESULTS INDICATE THAT THERE IS NO GOOD MATCH AVAILABLE IN THE LIBRARY, THE BEST MATCH IS MIXTURE OF CARBOXYLIC ACID SALTS AND OTHER UNKNOWN COMPOUNDS. THE EMBEDDED FOREIGN MATTER PARTICLES COULD BE GENERATED FROM THE MOLDING PROCESS. THERE IS A LAYER OF CARBONIZED MATERIAL AT THE INJECTION SCREW WHICH STARTS TO CRACK AS THE CARBONIZED MATERIAL BECOMES THICKER WHICH THUS BECOMES BLACK PARTICLES INJECTED INTO THE MOLD. THE LAYER OF CARBONIZED MATERIAL WAS GENERATED FROM PLASTIC REMAINS IN THE PLASTICIZING UNIT AND START TO CARBONIZE ON THE INNER WALL OF THE CYLINDER AND ON THE SCREW SURFACE. THE PROBABLE ROOT CAUSE FOR THE SAMPLE WITH BLACK FOREIGN MATTER ON THE HUB COLLAR COULD BE FROM THE DISCHARGE STATION WHEN THE NEEDLE HUB RUBS AGAINST THE EDGE OF THE DISCHARGE RAMP WHICH COULD HAVE CAUSED THE SCUFF MARK AND DIRT BEING TRANSFERRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 19G 1-1/2IN TW HAD FOREIGN MATTER INSIDE THE HUB. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT FROM HOSPITAL. THE USER COMPLAINED THAT BLACK FOREIGN MATTER WAS FOUND INSIDE THE HUB.

    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 #: 9143556. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-23. MEDICAL DEVICE LOT #: 9108849. MEDICAL DEVICE EXPIRATION DATE: 2024-04-30. DEVICE MANUFACTURE DATE: 2019-04-18. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 19G 1-1/2IN TW HAD FOREIGN MATTER INSIDE THE HUB. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT FROM HOSPITAL. THE USER COMPLAINED THAT BLACK FOREIGN MATTER WAS FOUND INSIDE THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445324 NEEDLE 19G 1-1/2IN TW NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other