BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17484265 · Received August 8, 2023

    Report

    Report Number
    1917413-2023-00745
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 11, 2023
    Report Date
    September 21, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 10-AUG-2023. H.6. INVESTIGATION SUMMARY: BD RECEIVED 10 SAMPLES AND NO PHOTOS FOR INVESTIGATION. THE 10 CUSTOMER SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. THEY WERE ALSO TESTED FOR HEPARIN ACTIVITY AND ALL WERE WITHIN SPECIFICATION. ADDITIONALLY, 84 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES BEING IDENTIFIED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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, CLOTTING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THERE HAS BEEN AN ISSUE OF CLOTTING IN 3 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS TUBES FROM LOT#: 2321408 CLOTTING. THIS HAS AFFECTED AT LEAST 3 TUBES FROM THIS LOT. ISSUE HAS PRESENTED WITH DIFFERENT PHLEBOTOMIST. ISSUE STARTED APPROXIMATELY ON 7/11."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES, THERE HAS BEEN AN ISSUE OF CLOTTING IN 3 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS TUBES FROM LOT#: 2321408 CLOTTING. THIS HAS AFFECTED AT LEAST 3 TUBES FROM THIS LOT. ISSUE HAS PRESENTED WITH DIFFERENT PHLEBOTOMIST. ISSUE STARTED APPROXIMATELY ON 7/11."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318055 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2321408 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown