BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ELASTOMER COATED LATEX CATHETER TRAY

    MDR report key: 3659897 · Received February 18, 2014

    Report

    Report Number
    1417592-2014-00021
    Event Type
    Injury
    Date Received
    February 18, 2014
    Report Date
    February 13, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTACT AT THE FACILITY INDICATED THAT THEY WERE UNSURE OF A DATE BUT THAT ONE OF THE NURSES STATED SHE ATTEMPTED TO INFLATE THE BALLOON ON TWO FOLEY CATHETERS FOR THE SAME PT BUT WAS UNSUCCESSFUL. THE CATHETER APPARENTLY FELL OUT. ON THE THIRD ATTEMPT, SHE WAS SUCCESSFUL. SHE DISCARDED THE CATHETER AND DID NOT INITIALLY REPORT IT. IN THE ABSENCE OF A SAMPLE, WE HAVE NOT CONFIRMED THE ISSUE AND A ROOT CAUSE HAS NOT BEEN DETERMINED. DUE TO THE REPORTED NEED FOR THE CATHETER TO BE RE-INSERTED, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE FACILITY INDICATED THEY DID NOT HAVE AN INCIDENT DATE BUT THAT THE FOLEY CATHETER BALLOON WOULD NOT INFLATE AND HAD TO BE REINSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102129 SILICONE ELASTOMER COATED LATEX CATHETER TRAY NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other