BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC: 1.0ML TUBE

    MDR report key: 8571083 · Received May 1, 2019

    Report

    Report Number
    1917413-2019-01416
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 21, 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

    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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REGEN¿ THT® NC: 1.0ML TUBE HAD FOREIGN MATTER IN IT, AND SOME WERE MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE THT TUBES AFTER MEETING IN THE REPORT FOREIGN MATTERS IN THE TUBES. STEP A (ASSEMBLY): 103 (103 TUBES WITH DUST); MISSING OR DEFECTIVE PARTS. STEP A (ASSEMBLY): 283 (5 TUBES WITH LABEL DAMAGED + 8 TUBES WITH GEL STICK IN THE GLASS + 62 TUBES WITH LABEL POORLY PRINTED + 2 BROKEN TUBES + 12 TUBES WITH STAIN ON THE LABEL + 134 TUBES WITCH SCRATCHES + 60 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 #: 8302644. MEDICAL DEVICE EXPIRATION DATE: 2020-11-30. DEVICE MANUFACTURE DATE: 2018-10-29. MEDICAL DEVICE LOT #: 8213957. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2018-08-01. MEDICAL DEVICE LOT #: 8243889. MEDICAL DEVICE EXPIRATION DATE: 2020-09-30. DEVICE MANUFACTURE DATE: 2018-08-31. (B)(6). 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: 1.0 ML TUBE HAD FOREIGN MATTER IN IT, AND SOME WERE MISSING LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE THT TUBES AFTER MEETING IN THE REPORT. FOREIGN MATTERS IN THE TUBES. STEP A (ASSEMBLY): 103. MISSING OR DEFECTIVE PARTS. STEP A (ASSEMBLY): 283. 103 TUBES WITH DUST, 5 TUBES WITH LABEL DAMAGED + 8 TUBES WITH GEL STICK IN THE GLASS, + 62 TUBES WITH LABEL POORLY PRINTED + 2 BROKEN TUBES + 12 TUBES WITH STAIN ON THE LABEL + 134 TUBES WITCH SCRATCHES + 60 TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361270 REGEN¿ THT® NC: 1.0ML TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H TAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other