BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION URINALYSIS CUP KIT: STERILE SCREW-CAP

    MDR report key: 7059104 · Received November 27, 2017

    Report

    Report Number
    1917413-2017-00235
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    September 25, 2015
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    UDI-DI
    00382903649891
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - ONE HUNDRED CUSTOMER SAMPLES WERE RETURNED. TWENTY WERE OBSERVED FOR STOPPER CREEPOUT/POP OFF. THE TUBES SAT AND WERE VISUALLY INSPECTED FOR CREEPOUT. THE TUBES WERE PICKED UP BY SHIELD ASSEMBLIES AND SHAKEN TO SEE IF THE STOPPER WOULD DISLODGE. STOPPER CREEPOUT WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4177818. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE DEVICE TYPE CODE AS JSM. IT IS CORRECTED TO READ KDT. THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS N/A. IT IS CORRECTED TO READ EXEMPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® URINE COLLECTION URINALYSIS CUP KIT: STERILE SCREW-CAP COLLECTION CUP WITH INTEGRATED TRANSFER DEVICE AND 8.0 ML, 16X100 MM PLUS PLASTIC CONICAL TUBE FOR URINALYSIS HAD A STOPPER COME OFF WHICH RESULTED IN A LEAK OF URINE INTO A BIOHAZARD BAG. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840669 BD VACUTAINER® URINE COLLECTION URINALYSIS CUP KIT: STERILE SCREW-CAP COLLECTION CUP KDT BECTON, DICKINSON & CO. 4177818 00382903649891

    Patients

    Seq Age Sex Outcome Treatment
    1 Other