BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR

    MDR report key: 15680652 · Received October 27, 2022

    Report

    Report Number
    3003916417-2022-00234
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 5, 2022
    Report Date
    January 18, 2023
    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 DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-12-21. H.6. INVESTIGATION SUMMARY: BD RECEIVED 20 SAMPLES FROM BATCH 2181428, 10 PHOTOS AND 1 VIDEO FROM THE CUSTOMER IN SUPPORT OF THIS INVESTIGATION. THE VIDEO AND PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR INSTRUMENT ISSUES WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES, ALONG WITH 5 RETENTION SAMPLES FROM EACH LOT OF THE BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND, THE INDICATED FAILURE MODES OF STOPPER DEFECT AND INSTRUMENT ISSUES WITH THE INCIDENT LOTS WERE 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 INSTRUMENT ISSUES BASED ON THE PHOTOS PROVIDED ; HOWEVER, THE ISSUE OF STOPPER DEFECT (RIGIDITY) COULD NOT BE CONFIRMED BASED ON THE RETENTION AND CUSTOMER SAMPLE TEST RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE OF INSTRUMENT ISSUES. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED WHEN USING THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR THE STOPPER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER RUBBER IS TOO RIGID, AND MAKING HARD THE SAMPLE COLLECTION. THE TUBES ARE WITH THE RUBBER CAP TOO HARD, MAKING IMPOSSIBLE THE PUNCTURE BY ANALYZER EQUIPMENT.".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR THE STOPPER WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER RUBBER IS TOO RIGID, AND MAKING HARD THE SAMPLE COLLECTION. THE TUBES ARE WITH THE RUBBER CAP TOO HARD, MAKING IMPOSSIBLE THE PUNCTURE BY ANALYZER EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2480633 BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2181428

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown