BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE PMS PLH 13X100 3.5 BLBL LIM CE

    MDR report key: 8509754 · Received April 12, 2019

    Report

    Report Number
    9617032-2019-00439
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    November 23, 2018
    Report Date
    July 19, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903650873
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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-CONFORMANCES 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 ERRONEOUS RESULTS OCCURRED WITH A TUBE PMS PLH 13X100 3.5 BLBL LIM CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE SITE ARE VALIDATING BD BARRICOR ALONGSIDE PST II AT THEIR SITE. THEY PERFORMED TWO STUDIES, ONE ON HEALTHY VOLUNTEERS, AND ONE ON PATIENTS FROM A GP. THE STUDY PERFORMED ON HEALTHY VOLUNTEERS USED THE PREANALYTICAL UNITS ON THEIR TRACK, 3000G CENTRIFUGATION FOR 8 MINUTES, THE GP SPECIMENS CENTRIFUGED ON-SITE, 4000G FOR 3 MINUTES. THE DATA SHOWED SIGNIFICANT DIFFERENCES IN LDH, WITH INCREASED SCATTER AND A BIAS. THIS DATA HAS BEEN PUBLISHED IN POSTER FORM AT EFLM".

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 ERRONEOUS RESULTS OCCURRED WITH A TUBE PMS PLH 13X100 3.5 BLBL LIM CE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE SITE ARE VALIDATING BD BARRICOR ALONGSIDE PST II AT THEIR SITE. THEY PERFORMED TWO STUDIES, ONE ON HEALTHY VOLUNTEERS, AND ONE ON PATIENTS FROM A GP. THE STUDY PERFORMED ON HEALTHY VOLUNTEERS USED THE PREANALYTICAL UNITS ON THEIR TRACK, 3000G CENTRIFUGATION FOR 8 MINUTES, THE GP SPECIMENS CENTRIFUGED ON-SITE, 4000G FOR 3 MINUTES. THE DATA SHOWED SIGNIFICANT DIFFERENCES IN LDH, WITH INCREASED SCATTER AND A BIAS. THIS DATA HAS BEEN PUBLISHED IN POSTER FORM AT (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300746 TUBE PMS PLH 13X100 3.5 BLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8199803 00382903650873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other