BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 7560058 · Received June 1, 2018

    Report

    Report Number
    1917413-2018-02279
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    November 17, 2017
    Report Date
    May 7, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903679602
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7180582, MEDICAL DEVICE EXPIRATION DATE: 07/31/2018, RETURNED TO MANUFACTURER ON: 01/15/2018, DEVICE MANUFACTURE DATE: 06/29/2017.". INVESTIGATION SUMMARY: BD HAD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR EVALUATION. THE SAMPLES WERE TESTED FOR DRAW VOLUME AND ALL SAMPLES DREW WITHIN REQUIRED SPECIFICATIONS. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR DRAW VOLUME TESTING AND UPON COMPLETION, THE CUSTOMER'S INDICATED FAILURE MODE FOR LOW DRAW VOLUME (UNDERFILL) WAS NOT OBSERVED AS ALL SAMPLES MET SPECIFICATIONS. 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 LOW DRAW VOLUME (UNDERFILL) WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: 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. 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 THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN N (LH) BLOOD COLLECTION TUBES UNDER FILING. NO SERIOUS INJURY MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404265 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 7180581 50382903679602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other