BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE PMS PLH 13X100 3.5 PLBL LIM CE

    MDR report key: 12197523 · Received July 20, 2021

    Report

    Report Number
    9617032-2021-00805
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 25, 2021
    Report Date
    August 17, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 4 PHOTOGRAPHS FROM THE CUSTOMER FOR EVALUATION. ONE PHOTO SHOWING A PIECE OF THE INSTRUMENT UTILIZED. OTHER PHOTOS SHOWED A BARRICOR TUBE WITH THE BLUE STOPPER IN IT AND, ANOTHER BARRICOR TUBE WITH GREY STOPPER IN THE TUBE. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR STOPPER POP OFF (CAP TORN OFF) WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 100 RETAINED SAMPLES WERE VISUALLY INSPECTED NO DEFECTS WERE FOUND. 10 RETAINED SAMPLES WERE FUNCTIONALLY TESTED, CAP/STOPPER ASSEMBLIES WERE REMOVED, THEN REATTACHED, SAMPLES WERE LEFT TO STAND FOR 4 HOURS. NONE OF THE CAP/STOPPER ASSEMBLIES POPPED OFF. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER POP OFF (CAP TORN OFF). BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TUBE PMS PLH 13X100 3.5 PLBL LIM CE, THE DEVICE EXPERIENCED BROKEN LIDS/CAPS, AND LABEL LIFT OFF/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SINCE THE END OF LAST WEEK, WE HAVE BEEN EXPERIENCING A PROBLEM WITH OUR BARRICOR TUBES. ONCE OR TWICE A DAY, WE FIND THAT A CAP IS BADLY TORN OFF BY OUR PRE-ANALYTICAL CHAIN (THERMO CHAIN). WE HAVE OBSERVED THIS PHENOMENON ONLY ON BARRICOR TUBES. YOU WILL FIND IN COPY AN EMAIL CONCERNING A PROBLEM OF UNBLOCKING BARRICOR TUBES REF (B)(4) FOR THE LOT 1067150 EXPIRY DATE 31-07-2022 . THIS CUSTOMER HAS SWITCHED TO BARRICOR TUBES SINCE THE BEGINNING OF DECEMBER 2020 ON THEIR NEW ORTHO CHAIN WITH A THERMO UNBLOCKER. FOR 7 DAYS NOW YOU HAVE HAD 2 TO 3 TUBES PER DAY WHERE THE CAP IS WELL UNCORKED BUT THE ELASTOMER PART OF THE CAP REMAINS IN THE TUBE WHICH LEADS TO AN ANOMALY ON THE AUTOMATONS AND ESPECIALLY A LONGER DELAY OF THE TAT IN THE PATIENT RESULT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHEN USING THE TUBE PMS PLH 13X100 3.5 PLBL LIM CE, THE DEVICE EXPERIENCED BROKEN LIDS/CAPS, AND LABEL LIFT OFF/PARTIAL PEEL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SINCE THE END OF LAST WEEK, WE HAVE BEEN EXPERIENCING A PROBLEM WITH OUR BARRICOR TUBES. ONCE OR TWICE A DAY, WE FIND THAT A CAP IS BADLY TORN OFF BY OUR PRE-ANALYTICAL CHAIN (THERMO CHAIN). WE HAVE OBSERVED THIS PHENOMENON ONLY ON BARRICOR TUBES. YOU WILL FIND IN COPY AN EMAIL CONCERNING A PROBLEM OF UNBLOCKING BARRICOR TUBES REF 365 053 FOR THE LOT 1067150 EXPIRY DATE 31-07-2022 . THIS CUSTOMER HAS SWITCHED TO BARRICOR TUBES SINCE THE BEGINNING OF (B)(6) 2020 ON THEIR NEW ORTHO CHAIN WITH A THERMO UNBLOCKER. FOR 7 DAYS NOW YOU HAVE HAD 2 TO 3 TUBES PER DAY WHERE THE CAP IS WELL UNCORKED BUT THE ELASTOMER PART OF THE CAP REMAINS IN THE TUBE WHICH LEADS TO AN ANOMALY ON THE AUTOMATONS AND ESPECIALLY A LONGER DELAY OF THE TAT IN THE PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092810 TUBE PMS PLH 13X100 3.5 PLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1067150

    Patients

    Seq Age Sex Outcome Treatment
    1