BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 16714623 · Received April 11, 2023

    Report

    Report Number
    9617032-2023-00380
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 14, 2023
    Report Date
    March 21, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: 2020949, D4. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, H4. DEVICE MANUFACTURE DATE: 2022-01-20. H.6 INVESTIGATION SUMMARY: MATERIAL #: 367374, LOT/BATCH #: 2175089, 2020949. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 20 RETAINED SAMPLES FROM EACH LOT NUMBER 2175089; 2020949 WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 40 TUBES DREW WITHIN SPECIFICATION. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. 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 THAT WHILE USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THAT THERE WAS UNDERFILL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MANY OF TUBES DON'T FILLED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623299 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2175089

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown