BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X75 3.5 PLBL GOLD BR

    MDR report key: 12865644 · Received November 23, 2021

    Report

    Report Number
    3003916417-2021-00355
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 21, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1116546 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30 H.4. DEVICE MANUFACTURE DATE: 2021-05-20 D.4. MEDICAL DEVICE LOT #: 1181432 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30 H.4. DEVICE MANUFACTURE DATE: 2021-07-22 D.4. MEDICAL DEVICE LOT #: 1181434 D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30 H.4. DEVICE MANUFACTURE DATE: 2021-07-22 H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL BUBBLES WAS OBSERVED FOR BATCH NUMBER 1181432. ADDITIONALLY, TWO HUNDRED (200) RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION. THE ISSUE OF GEL BUBBLES WAS OBSERVED IN THREE RETENTION SAMPLES FOR BATCH NUMBER 1116546. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF GEL BUBBLES FOR BATCHES 1181432 AND 1116546 BASED ON RETURNED PHOTOS AND RETAIN TESTING. IT WAS NOT POSSIBLE TO CONFIRM GEL BUBBLES FOR BATCH NUMBER 1181434 BASED ON THE INFORMATION PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1116546. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-05-20. MEDICAL DEVICE LOT #: 1181432. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2021-07-22. 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 · 0

    IT WAS REPORTED THAT 501 TUBE SST PLH 13X75 3.5 PLBL GOLD BR HAD AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES ARE WITH DIFFERENT GEL CHARACTERISTICS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 501 TUBE SST PLH 13X75 3.5 PLBL GOLD BR HAD AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES ARE WITH DIFFERENT GEL CHARACTERISTICS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759727 TUBE SST PLH 13X75 3.5 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown