BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 15556383 · Received October 6, 2022

    Report

    Report Number
    1024879-2022-00591
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 14, 2022
    Report Date
    October 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS AND ONE (1) VIDEO WERE PROVIDED FOR INVESTIGATION. THE PHOTOS AND VIDEO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL AND TUBE PUSH OFF WAS OBSERVED. ADDITIONALLY, TWENTY (20) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF UNDERFILL AND TUBE PUSH 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 OF UNDERFILL AND TUBE PUSH OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES DOES NOT FILL, AND HAS TOO MUCH FORCE TO INSERT IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ON (B)(6) 2022, TUBES THAT DO NOT HAVE VACUUM ARE IDENTIFIED DURING SAMPLING, AND CAUSE VENIPUNCTURE FAILURES. ADDITIONALLY, THIS REQUIRES TOO MUCH FORCE TO INSERT THE NEEDLE, THEY ARE REINTRODUCED, AND IN MANY CASES THEY DO NOT FILL COMPLETELY. THIS HAPPENED TO ME. HOWEVER, CONSULTING WITH THE AUXILIARIES, THEY INFORM ME THAT IT HAS HAPPENED TO THEM CONSTANTLY. LOT 2081971, FV 2023-03-031."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES DOES NOT FILL, AND HAS TOO MUCH FORCE TO INSERT IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ON 06 09 2022 AND 07 09 2022, TUBES THAT DO NOT HAVE VACUUM ARE IDENTIFIED DURING SAMPLING, AND CAUSE VENIPUNCTURE FAILURES. ADDITIONALLY, THIS REQUIRES TOO MUCH FORCE TO INSERT THE NEEDLE, THEY ARE REINTRODUCED, AND IN MANY CASES THEY DO NOT FILL COMPLETELY. THIS HAPPENED TO ME. HOWEVER, CONSULTING WITH THE AUXILIARIES, THEY INFORM ME THAT IT HAS HAPPENED TO THEM CONSTANTLY. LOT 2081971 FV 2023-03-031.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387168 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES 50382903679862 JKA BECTON, DICKINSON & CO., (BD) 367986 2081971 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown