BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 24698668 · Received March 26, 2026

    Report

    Report Number
    9617032-2026-00356
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 3, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED 6 PHOTOS FOR INVESTIGATION. THE EVALUATION OF THE PHOTOS SHOWED A LABEL THAT BD DOES NOT APPLY; THEREFORE, THIS EVIDENCE COULD NOT BE EVALUATED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR LOT 5171820, FOR THE INDICATED FAILURE MODE: INCORRECT/MISSING LABEL INFORMATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, THE MANUFACTURING DATE IS MISSING, AND THE IMPORT DATE SEEMS TO BE INCORRECT FOR AN UNSPECIFIED NUMBER OF SHELF PACKS. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308897 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 5171820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown