BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 16687178 · Received April 5, 2023

    Report

    Report Number
    9617032-2023-00358
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 13, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS ANOTHER LOT REPORTED. BELOW IS THE INFORMATION FOR THAT LOT. MEDICAL DEVICE LOT #: 2122520. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2022-05-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR POOR SERUM WAS OBSERVED (SAMPLE APPEARED HEMOLYZED). ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR POOR SERUM AND ERRONEOUS RESULTS WAS NOT OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES EXHIBITED PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS-LACTATE DEHYDROGENASE AND POOR PLASMA) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. 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 HAS BEEN CONFIRMED FOR POOR PLASMA BASED ON THE HEMOLYSIS SEEN IN THE PHOTO; IT HAS NOT BEEN CONFIRMED FOR ERRONEOUS RESULTS. ALL RETENTION SAMPLE TESTING WAS SATISFACTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE OF LACTATE DEHYDROGENENASE INCREASING IN BD VACUTAINER PST PRIMARY TUBE AFTER SEVERAL HOURS AT ROOM TEMP (BUT STABLE IN SEPARATE ALIQUOT), THEY SUSPECT PLATELET CONTAMINATION OF THE PLASMA SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE OF LACTATE DEHYDROGENENASE INCREASING IN BD VACUTAINER PST PRIMARY TUBE AFTER SEVERAL HOURS AT ROOM TEMP (BUT STABLE IN SEPARATE ALIQUOT), THEY SUSPECT PLATELET CONTAMINATION OF THE PLASMA SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755177 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2143155

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown