BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 16714640 · Received April 11, 2023

    Report

    Report Number
    1917413-2023-00282
    Event Type
    Malfunction
    Date Received
    April 11, 2023
    Date of Event
    March 18, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE CUSTOMER STATES, A PHLEBOTOMIST MIGHT HAVE POURED OVER ANOTHER TUBE INTO THIS TUBE. CUSTOMER STATES, THIS HAS HAPPENED BEFORE. A GOLD TOP (PRODUCT # 367986) WAS RUN AS WELL, AND ALL CHEMISTRY RESULTS WERE WITHIN ACCEPTABLE RANGES. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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. H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT DURING USE WITH BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, ERRONEOUS RESULTS WERE OBTAINED. RESULTS WERE NOT REPORTED. AND THERE WAS NO PATIENT IMPACT. PATIENT 2 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER, ERRONEOUS RESULTS. CUSTOMER STATES, PHLEBOTOMIST MIGHT HAVE POURED OVER ANOTHER TUBE INTO THIS TUBE. CUSTOMER STATES, THIS HAS HAPPENED BEFORE. GOLD TOP (PRODUCT # 367986) WAS RUN AS WELL, AND ALL CHEMISTRY RESULTS WERE WITHIN ACCEPTABLE RANGES. 2ND PATIENT: ALB, CA, K, CO2, CL, TBIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773395 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 UNKNOWN 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown