BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® HEMOGARD¿ GLASS STERILE TUBES

    MDR report key: 7089322 · Received December 6, 2017

    Report

    Report Number
    1917413-2017-00427
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    December 16, 2016
    Report Date
    November 16, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #5251673 AND NO ISSUES WERE IDENTIFIED. DHR WAS REVIEWED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BD HAS INITIATED A CAPA TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. CAPA (B)(4) HAS BEEN OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP OF BD VACUTAINER® GLASS STERILE TUBES, SILICONIZED INTERIOR, 0.105M BUFFERED SODIUM CITRATE, HEMOGARD¿ CLOSURE, SEE THRU LABEL, 4.5.ML DRAW DETACHED AFTER BLOOD COLLECTION. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865026 BD VACUTAINER® HEMOGARD¿ GLASS STERILE TUBES BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 5251673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other