BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR

    MDR report key: 15996997 · Received December 16, 2022

    Report

    Report Number
    3003916417-2022-00293
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 19, 2022
    Report Date
    July 15, 2024
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 360059. LOT/BATCH #: 2243617. BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF IN CENTRIFUGE WAS OBSERVED. ADDITIONALLY, TWO HUNDRED (200) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF STOPPER POP OFF WAS NOT OBSERVED. 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER POP OFF IN CENTRIFUGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPS OUT OF THE TUBE AND STOPPER PULLS OUT OF TUBE WHEN IN AN ANALYZER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TECHNICAL AREA OF THE LABORATORY CONTINUES TO SIGNAL THE OPENING OF THE GEL TUBE LID, BOTH BEFORE COLLECTION/USE ON THE PATIENT AND DURING TRANSPORT/CENTRIFUGATION. THE SITUATION HAS CAUSED DISRUPTION IN THE ROUTINE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPS OUT OF THE TUBE AND STOPPER PULLS OUT OF TUBE WHEN IN AN ANALYZER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TECHNICAL AREA OF THE LABORATORY CONTINUES TO SIGNAL THE OPENING OF THE GEL TUBE LID, BOTH BEFORE COLLECTION/USE ON THE PATIENT AND DURING TRANSPORT/CENTRIFUGATION. THE SITUATION HAS CAUSED DISRUPTION IN THE ROUTINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152137 BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2243617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown