BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® COMPLETE URNINE COLLECTION KIT

    MDR report key: 7089170 · Received December 6, 2017

    Report

    Report Number
    1917413-2017-00480
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    June 12, 2017
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE DEVICE TYPE CODE LISTED AS KDT. IT IS CORRECTED TO READ JSM.

    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 AND NO ISSUES WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SLEEVE WAS STICKING DOWN AFTER FILLING THE TUBES WITH URINE, RESULTING IN URINE LEAKING IN THE SPECIMEN BAGS. OCCURING SEVERAL TIMES WITH THE COMPLETE KIT FOR MICROBIOLOGY & UA CHEMISTRY URINE TESTING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865685 BD VACUTAINER® COMPLETE URNINE COLLECTION KIT MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE JSM BECTON, DICKINSON & CO. 7010584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other