BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PST GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBES

    MDR report key: 10446481 · Received August 24, 2020

    Report

    Report Number
    1917413-2020-00749
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Date of Event
    June 25, 2020
    Report Date
    February 4, 2021
    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
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 POOR BARRIER SEPARATION OR ERRONEOUS RESULTS WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS AND POOR SEPARATION) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE CUSTOMER LOT SAMPLES. REPLICATES OF ANALYTES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY . VISUAL EVALUATIONS FOR SEPARATION DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. THIS COMPLAINT IS NOT CONFIRMED WITH RESPECT TO ERRONEOUS RESULTS AND POOR SEPARATION. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PLASMA HAD "WHITE FLOATIES" AND GEL APPEARED SPOTTED WITH RED CELLS. PER EMAIL: INCIDENT DETAILS: LABORATORY CHEMISTRY UNABLE TO BE ACCURATELY TESTED DUE TO FAULTY COLLECTION TUBE. APPEARANCE OF PLASMA HAD "WHITE FLOATIES" THROUGHOUT SAMPLE. SEPARATOR GEL APPEARED SPOTTED WITH RED CELLS. UNABLE TO OBTAIN RESULTS FOR K, MG AND CA - HAD THE APPEARANCE OF AN EDTA CONTAMINATED SAMPLE OFF OF THE LI HEPARIN PST TUBE. WAS ABLE TO LOCATE A SECOND TUBE COLLECTED FROM SAME PATIENT WHICH YIELDED RESULTS. APPEARS TO BE A ONE-OFF FAULTY COLLECTION TUBE AFTER EXTENSIVE INVESTIGATION."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES HAD POOR BARRIER SEPARATION AND ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PLASMA HAD "WHITE FLOATIES" AND GEL APPEARED SPOTTED WITH RED CELLS. PER EMAIL: INCIDENT DETAILS: LABORATORY CHEMISTRY UNABLE TO BE ACCURATELY TESTED DUE TO FAULTY COLLECTION TUBE. APPEARANCE OF PLASMA HAD "WHITE FLOATIES" THROUGHOUT SAMPLE. SEPARATOR GEL APPEARED SPOTTED WITH RED CELLS. UNABLE TO OBTAIN RESULTS FOR K, MG AND CA, HAD THE APPEARANCE OF AN EDTA CONTAMINATED SAMPLE OFF OF THE LI HEPARIN PST TUBE. WAS ABLE TO LOCATE A SECOND TUBE COLLECTED FROM SAME PATIENT WHICH YIELDED RESULTS. APPEARS TO BE A ONE-OFF FAULTY COLLECTION TUBE AFTER EXTENSIVE INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911047 BD VACUTAINER PST GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367960 0010746 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other