BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD VACUTAINER BLOOD COLLECTION TUBE

    MDR report key: 2253168 · Received September 1, 2011

    Report

    Report Number
    1917413-2011-00003
    Event Type
    Other
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BD
    Product Code
    JKA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT HISTORY CHECK WAS DONE AND THIS IS THE FIRST COMPLAINT RECORDED AGAINST THE IDENTIFIED LOT. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO ISSUES WERE FOUND. THE CUSTOMER INDICATED THAT SAMPLES FROM THE INCIDENT LOT WOULD BE SENT, BUT NONE WERE RECEIVED TO DATE. RETAINED SAMPLES WERE EVALUATED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE RESULTS ARE ENTERED IN THE EVAL SUMMARY. THE FOLLOWING IS A SUMMARY OF THE RECOMMENDED HANDLING OF PLUS PST TUBES: ALL TUBES SHOULD BE CHECKED TO CONFIRM THAT THEY ARE FILLED TO THE PROPER LEVEL. IF MULTIPLE TUBES ARE BEING DRAWN, LITHIUM HEPARIN TUBES SHOULD BE DRAWN AFTER ANY NON-ADDITIVE OR CITRATE TUBES. AFTER COLLECTION, THE PST SAMPLE TUBES SHOULD BE MIXED BY 8 - 10 COMPLETE INVERSIONS. LITHIUM HEPARIN ADDITIVE TUBES SHOULD BE CENTRIFUGED AT 1100 - 1300 RCF FOR TEN MINUTES WITHIN 2 HOURS OF COLLECTION. EXCESSIVE MIXING, A TRAUMATIC VENIPUNCTURE OR A CENTRIFUGE THAT IS NOT PROPERLY CALIBRATED CAN ALSO CONTRIBUTE TO ERRONEOUS RESULTS. REGULATORY COMPLIANCE WILL CONTINUE TO TRACK AND TREND THE REPORTED CONDITION. EVAL SUMMARY: TWENTY (20) RETENTION TUBES FROM LOT #1010785, ALONG WITH ONE (1) TUBES FROM A CONTROL LOT WERE SELECTED FOR EVAL. THERE WERE NO DIFFICULTIES DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. AFTER CENTRIFUGATION, THERE WAS COMPLETE GEL BARRIER FORMATION AND THE PLASMA WAS OF ACCEPTABLE QUALITY. THERE WAS NO HEMOLYSIS, FIBRIN OR GEL FRAGMENTS OBSERVED. POTASSIUM AND LD ASSAYS WERE PERFORMED ON BOTH RETENTION AND CONTROL LOT SAMPLES. THE TUBES DEMONSTRATED SATISFACTORY PERFORMANCE WITH NO CLINICAL DIFFERENCES OBSERVED. UNABLE TO CONFIRM THAT THE REPORTED CONDITION WAS RELATED TO THE MFG PROCESS AND/OR THE PERFORMANCE OF THE TUBES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PT WAS ADMITTED TO THE ER DUE TO ELEVATED (ERRONEOUS) POTASSIUM (K+) RESULTS. HOWEVER, WHEN THE TESTS WERE REPEATED, THE RESULTS WERE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER BLOOD COLLECTION TUBE 13 X 75 PLASMA SEPARATOR TUBE JKA BD NA 1010785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization