BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN THT NC: 1.0ML

    MDR report key: 10772275 · Received November 2, 2020

    Report

    Report Number
    1917413-2020-01038
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 12, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER, INK SMEAR/ PRINTING AND TUBE BREAKAGE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS WERE DEFECTIVE AND FOREIGN MATTER DISCOVERED WITH A REGEN¿ THT® NC: 1.0ML. THIS OCCURRED WITH NUMEROUS TUBES FROM 5 LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: MANY TUBES HAVE BEEN SENT BACK DUE TO DIFFERENT ISSUES (DEFECT LABEL, SPOTS ON TUBES, ETC). LOT 8302644 - WAS DELIVERED IN FEBRUARY 2019: 400 PIECES - TWO PCS. WITH 1 BROKEN TUBE IN EACH A PCK WITH 6 SPOTTED TUBES. A PCK WITH A DEFECTIVE LABEL. 1233 PIECES OPEN IN A BOX WITH VARIOUS DEFECTS (LINES ON GLASS.) LOT 9003661 - WAS DELIVERED IN AUGUST 2019. 388 PIECES - VARIOUS ERRORS. 1500 PIECES - VARIOUS ERRORS. LOT 9058514 - WAS DELIVERED IN AUGUST 2019. 1002 PIECES - VARIOUS ERRORS. 1500 PIECES - VARIOUS ERRORS. LOT 8340757 - WAS DELIVERED IN APRIL 2019. 908 PIECES - VARIOUS ERRORS. LOT 8269728 - WERE DELIVERED IN JANUARY 2019. 466 PIECES - VARIOUS ERROR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8269728, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2018-09-26, MEDICAL DEVICE LOT #: 8302644, MEDICAL DEVICE EXPIRATION DATE: 2020-11-30, DEVICE MANUFACTURE DATE: 2018-10-29, MEDICAL DEVICE LOT #: 8340757, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2018-12-06, MEDICAL DEVICE LOT #: 9003661, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2019-01-03, MEDICAL DEVICE LOT #: 9058514, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2019-02-27. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABELS WERE DEFECTIVE AND FOREIGN MATTER DISCOVERED WITH A REGEN¿ THT® NC: 1.0ML. THIS OCCURRED WITH NUMEROUS TUBES FROM 5 LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: MANY TUBES HAVE BEEN SENT BACK DUE TO DIFFERENT ISSUES (DEFECT LABEL, SPOTS ON TUBES, ETC). LOT 8302644: WAS DELIVERED IN FEBRUARY 2019: 400 PIECES: TWO PCS. WITH 1 BROKEN TUBE IN EACH, A PCK WITH 6 SPOTTED TUBES, A PCK WITH A DEFECTIVE LABEL. 1233 PIECES OPEN IN A BOX WITH VARIOUS DEFECTS (LINES ON GLASS...). LOT 9003661: WAS DELIVERED IN AUGUST 2019: 388 PIECES: VARIOUS ERRORS, 1500 PIECES: VARIOUS ERRORS. LOT 9058514: WAS DELIVERED IN AUGUST 2019: 1002 PIECES: VARIOUS ERRORS, 1500 PIECES: VARIOUS ERRORS. LOT 8340757: WAS DELIVERED IN APRIL 2019: 908 PIECES: VARIOUS ERRORS. LOT 8269728: WERE DELIVERED IN JANUARY 2019: 466 PIECES: VARIOUS ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234008 REGEN THT NC: 1.0ML NA JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1