BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC: 1.0ML

    MDR report key: 9140342 · Received October 1, 2019

    Report

    Report Number
    1917413-2019-02148
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REGEN¿ THT® NC: 1.0ML TUBES HAVE DEFECTS. THIS OCCURRED ON 3010 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2159 TUBES OF ONE LOT AND 851 TUBES OF ANOTHER WERE NOT COMPLIANT. SEVERAL USUAL DAMAGES COULD BE OBSERVED (AS HAS HAPPENED BEFORE WITH THESE TUBES).

    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 #: 8269727. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2018-09-26. MEDICAL DEVICE LOT #: 8243889 MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE:2018-08-31. 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 REGEN¿ THT® NC: 1.0ML TUBES HAVE DEFECTS. THIS OCCURRED ON 3010 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2159 TUBES OF ONE LOT AND 851 TUBES OF ANOTHER WERE NOT COMPLIANT. SEVERAL USUAL DAMAGES COULD BE OBSERVED (AS HAS HAPPENED BEFORE WITH THESE TUBES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937504 REGEN¿ THT® NC: 1.0ML N/A JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other