BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC: 1.0ML

    MDR report key: 14705051 · Received June 15, 2022

    Report

    Report Number
    1917413-2022-00323
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 23, 2022
    Report Date
    May 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    GIM
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1243282. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2021-08-31. MEDICAL DEVICE LOT #: 1243283 . MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2021-08-31. MEDICAL DEVICE LOT #: 1259063. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2021-09-16. INVESTIGATION SUMMARY: BD RECEIVED 5 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. A VISUAL EXAMINATION OF PHOTOS WAS PERFORMED AND THE CUSTOMER'S INDICATED FAILURE MODES OF FOREIGN MATTER ON THE INSIDE OF THE TUBE AND MISSING PRINT OF THE TUBE LABEL WAS OBSERVED. ADDITIONALLY, 100 RETENTIONS FROM EACH LOT WERE INSPECTED WITH NO ISSUES BEING IDENTIFIED WITH THE LABELS AND NO FOREIGN MATTER WAS SEEN IN THE TUBES. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE PHOTOS PROVIDED. THE EXACT CAUSE OF THE CUSTOMER¿S FAILURE MODE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE REGEN¿ THT® NC: 1.0ML THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL AND NO LABEL OR MISSING LABEL INFORMATION. THE FOREIGN MATTER EVENT OCCURRED 3 TIMES. THE ILLEGIBLE LABEL EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING THE VISUAL INSPECTION. THERE WAS A BLACK SPOT IN THE GEL OR IN THE TUBE, ILLEGIBLE LABEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910406 REGEN¿ THT® NC: 1.0ML NA GIM BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown