BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE TOTAL ONE LAYER FOLEY CATHETER TRAY

    MDR report key: 5678174 · Received May 25, 2016

    Report

    Report Number
    5678174
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Date of Event
    April 17, 2016
    Report Date
    May 5, 2016
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE NURSE STATED WHEN SHE WENT TO TAKE A SAMPLE FROM THE PORT, THE PORT BROKE OFF OF THE MAIN TUBING. THE PRODUCT WAS NOT SAVED BUT PICTURES WERE TAKEN. MANUFACTURER RESPONSE FOR UROLOGICAL TUBING, MEDLINE (PER SITE REPORTER): THE SALES REP ASKED FOR THE PICTURES THAT WERE TAKEN AND THEY WERE SENT. THE NEXT DAY THE REP ASKED TO INSPECT OUR LOT #'S. THE REP STATED MEDLINE HAD MADE SOME MODIFICATIONS TO THE PRODUCT AND MEDLINE WOULD LIKE TO CHANGE OUT CERTAIN LOT #'S IF WE HAVE THEM ON HAND. (AT THIS TIME THE LOT #S ARE STILL UNKNOWN TO US).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334728 SILICONE TOTAL ONE LAYER FOLEY CATHETER TRAY KIT, URINARY CATHETER NWR MEDLINE INDUSTRIES INC URO170816S 15KB0133 (POSSIBLE LOT)

    Patients

    Seq Age Sex Outcome Treatment
    1