BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBE

    MDR report key: 12240038 · Received July 28, 2021

    Report

    Report Number
    9617032-2021-00827
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    July 7, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K901449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: SHORT DESCRIPTION: POOR SEPARATOR MOVEMENT B.5. EVENT OR PROBLEM:11AUG2021 - ADDITIONAL INFORMATION PROVIDED FROM RCC: THE CUSTOMER STATED: "IT IS NOT CLEAR WHETHER THERE IS A DEFECT REGARDING THE TUBES, THEY NOTICED A CHANGE WHEN PREPARING ALIQUOTS WITH REGARD TO THE CONSISTENCE OF THE BLOOD.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO SAMPLE QUALITY WERE OBSERVED. 10 RETAINED SAMPLES FROM THE LOT NUMBER PROVIDED, WERE ANALYZED FOR HEPARIN CONTENT; ALL WERE FOUND TO BE WITHIN SPECIFICATION. FURTHER TESTING INDICATED ALL TUBES FILLED AS EXPECTED AND ALL RESULTS WERE NORMAL. NO HEMOLYSIS OR CLOTTING WAS DETECTED IN ANY OF THE TUBES TESTED. BLOOD APPEARED TO BE OF THE EXPECTED CONSISTENCY. VISUAL EVALUATIONS OF RETAINED AND CONTROL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. 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 SAMPLE QUALITY ISSUES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBE THERE WAS HEMOLYSIS AND POOR SEPARATOR MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PREPARING ALIQUOTS OF THE WHOLE BLOOD SAMPLE, BLOOD GETS ON THE PIPETTE BODY AND 30% OF THE SAMPLES HAVE HEMOLYSIS. THIS OCCURS AFTER INCUBATION IN SPECIAL TUBES WITH LYOPHILIZED ANTIGEN."(B)(6) 2021/PW - 1ST ISSUE IS UNCLEAR AFTER FOLLOW UP ATTEMPTS BUT APPEARS TO BE RELATED TO SAMPLE QUALITY FOR CONSISTENCY OF SAMPLE - WILL REQUEST TITRATION 11AUG2021 - ADDITIONAL INFORMATION PROVIDED FROM RCC: THE CUSTOMER STATED: "IT IS NOT CLEAR WHETHER THERE IS A DEFECT REGARDING THE TUBES, THEY NOTICED A CHANGE WHEN PREPARING ALIQUOTS WITH REGARD TO THE CONSISTENCE OF THE BLOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBE THERE WAS HEMOLYSIS AND POOR SEPARATOR MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PREPARING ALIQUOTS OF THE WHOLE BLOOD SAMPLE, BLOOD GETS ON THE PIPETTE BODY AND 30% OF THE SAMPLES HAVE HEMOLYSIS. THIS OCCURS AFTER INCUBATION IN SPECIAL TUBES WITH LYOPHILIZED ANTIGEN."11AUG2021/PW - 1ST ISSUE IS UNCLEAR AFTER FOLLOW UP ATTEMPTS BUT APPEARS TO BE RELATED TO SAMPLE QUALITY FOR CONSISTENCY OF SAMPLE - WILL REQUEST TITRATION. 11AUG2021 - ADDITIONAL INFORMATION PROVIDED FROM RCC: THE CUSTOMER STATED: "IT IS NOT CLEAR WHETHER THERE IS A DEFECT REGARDING THE TUBES, THEY NOTICED A CHANGE WHEN PREPARING ALIQUOTS WITH REGARD TO THE CONSISTENCE OF THE BLOOD.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBE THERE WAS HEMOLYSIS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PREPARING ALIQUOTS OF THE WHOLE BLOOD SAMPLE, BLOOD GETS ON THE PIPETTE BODY AND 30% OF THE SAMPLES HAVE HEMOLYSIS. THIS OCCURS AFTER INCUBATION IN SPECIAL TUBES WITH LYOPHILIZED ANTIGEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136942 BD VACUTAINER® LH (LITHIUM HEPARIN) 68 I.U. PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1061209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown