BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE PMS PLH 13X100 3.5 BLBL LIM CE

    MDR report key: 8506908 · Received April 11, 2019

    Report

    Report Number
    9617032-2019-00434
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    September 13, 2018
    Report Date
    July 19, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCE'S DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#1061510. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#1061510. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA#1061510 TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 26 TUBE PMS PLH 13X100 3.5 BLBL LIM CE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIGNIFICANT DIFFERENCE IN LDH DATA BETWEEN BARRICOR AND GREINER SERUM TUBES THE CUSTOMER HAS BEEN VALIDATING BARRICOR TUBES ALONGSIDE THEIR USUAL GREINER SERUM TUBES, USING CLINICAL OUTPATIENTS. THEY ARE SATISFIED WITH THE VALIDATION, BUT HAVE NOTED A SIGNIFICANT DIFFERENCE BETWEEN LDH RESULTS, WHEN COMPARING BARRICOR AND GREINER SERUM DATA. THE TUBES WERE THE 3.5 ML VARIANT, CENTRIFUGED OFF-LINE ON BECKMAN COULTER ALLEGRA CENTRIFUGES AT 3600RPM FOR 5 MINUTES.

    Additional Manufacturer Narrative · 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 · 1

    IT WAS REPORTED THAT 26 TUBE PMS PLH 13 X 100 3.5 BLBL LIM CE EXPERIENCED ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIGNIFICANT DIFFERENCE IN LDH DATA BETWEEN BARRICOR AND GREINER SERUM TUBES. THE CUSTOMER HAS BEEN VALIDATING BARRICOR TUBES ALONGSIDE THEIR USUAL GREINER SERUM TUBES, USING CLINICAL OUTPATIENTS. THEY ARE SATISFIED WITH THE VALIDATION, BUT HAVE NOTED A SIGNIFICANT DIFFERENCE BETWEEN LDH RESULTS, WHEN COMPARING BARRICOR AND GREINER SERUM DATA. THE TUBES WERE THE 3.5 ML VARIANT, CENTRIFUGED OFF-LINE ON BECKMAN COULTER ALLEGRA CENTRIFUGES AT 3600 RPM FOR 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300437 TUBE PMS PLH 13X100 3.5 BLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8009904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other