BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 11917363 · Received June 1, 2021

    Report

    Report Number
    3003916417-2021-00120
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 29, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FIBRIN AND HEMOLYSIS WAS OBSERVED. WE CANNOT CONFIRM CLOGGING OF THE INSTRUMENT PROBE BASED ON THE PHOTOS. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO FIBRIN OR HEMOLYSIS WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE: FIBRIN AND HEMOLYSIS BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. 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. THIS COMPLAINT HAS BEEN CONFIRMED FOR FIBRIN AND HEMOLYSIS BASED ON THE PHOTOS PROVIDED. TESTING OF RETENTION SAMPLES WAS SATISFACTORY. CAPA#1654520 WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR, THE DEVICE EXPERIENCED CLOGGED/BLOCKED INSTRUMENTATION PROBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE SAMPLES AFTER CENTRIFUGATION REMAIN CLOGGED.

    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 #: 0111089. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2020-06-19. MEDICAL DEVICE LOT #: 0151866. MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. DEVICE MANUFACTURE DATE: 2020-06-26. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR, THE DEVICE EXPERIENCED CLOGGED/BLOCKED INSTRUMENTATION PROBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE SAMPLES AFTER CENTRIFUGATION REMAIN CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811110 BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 0151866

    Patients

    Seq Age Sex Outcome Treatment
    1