BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION STRAW

    MDR report key: 7008101 · Received November 7, 2017

    Report

    Report Number
    1917413-2017-00162
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    May 23, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5355596. THE PHOTO SENT SHOWED THE STRAW DETACHED FROM THE HOLDER. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS K790366. IT IS CORRECTED TO READ EXEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® URINE COLLECTION STRAW HAD THE NEEDLE EXPOSED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO MUCOUS MEMBRANE EXPOSURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785628 BD VACUTAINER® URINE COLLECTION STRAW URINE COLLECTION SET. KDT BECTON, DICKINSON & CO. 5355596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other