BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 7587370 · Received June 11, 2018

    Report

    Report Number
    1917413-2018-01877
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    November 24, 2017
    Report Date
    May 23, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7130953, MEDICAL DEVICE EXPIRATION DATE: 05/31/2018, DEVICE MANUFACTURE DATE: 05/10/2017. (B)(6). INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE CUSTOMER'S INDICATED FAILURE MODE FOR AIR BUBBLES WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER AND RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO AIR POCKETS IN THE GEL MATERIAL OR BY AIR IN THE LINES DURING THE DISPENSE PROCESS. THERE ARE PURGES THAT ALLOW THE OPERATORS TO MINIMIZE THE AMOUNT OF AIR BUBBLES PRODUCED FROM AIR IN THE LINES, AND INSPECTIONS THAT MINIMIZE THE AMOUNT OF TUBES RELEASED THAT HAVE AIR BUBBLES CAUSED BY THE AIR POCKETS. IF SMALL BUBBLES ARE PRESENT IN GEL PRODUCT WHEN THE PRODUCT IS STERILIZED, THESE BUBBLES MAY BECOME LARGER DUE TO THE HEAT. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG HAD AIR BUBBLES IN THE GEL. NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432238 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7067665 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other