BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBE GLU PLH 13X75 2.0 SLBL GR O

    MDR report key: 7286544 · Received February 21, 2018

    Report

    Report Number
    1917413-2018-00026
    Event Type
    Malfunction
    Date Received
    February 21, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 9, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DAMAGE AND MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND DAMAGE AND MOLDING DEFECT 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR DAMAGE AND MOLDING DEFECT WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS CONDUCTED AND DAMAGE AND MOLDING DEFECT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 SHIELD OF A BD¿ TUBE GLU PLH 13X75 2.0 SLBL GR O WAS CRACKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131023 BD¿ TUBE GLU PLH 13X75 2.0 SLBL GR O BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 7180574

    Patients

    Seq Age Sex Outcome Treatment
    1 Other