BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES

    MDR report key: 17028475 · Received May 30, 2023

    Report

    Report Number
    9617032-2023-00627
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 4, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED. 10 RETAINED SAMPLES, FROM THE IMPLICATED LOT NUMBER, WERE ANALYZED FOR HEPARIN CONTENT. ALL 10 TUBES WERE 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. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023. AT THIS TIME , FURTHER TESTING IS NOT INDICATED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE HEMOLYSIS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDR 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES THAT THERE WAS HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE SEEN A SIGNIFICANT INCREASE IN TUBES WITH HEMOLYZED PLASMA. THESE ARE STANDARD GREEN EMPTY CAP TUBES (REF 368496). AN INITIAL ANALYSIS LEADS US TO SUSPECT A LINK BETWEEN THIS PROBLEM AND LOT 3010305.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES THAT THERE WAS HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE SEEN A SIGNIFICANT INCREASE IN TUBES WITH HEMOLYZED PLASMA. THESE ARE STANDARD GREEN EMPTY CAP TUBES (REF (B)(4)). AN INITIAL ANALYSIS LEADS US TO SUSPECT A LINK BETWEEN THIS PROBLEM AND LOT 3010305.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029596 BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3010305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown