BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ELASTOMER COATED LATEX CATHETER TRAY

    MDR report key: 3708940 · Received January 13, 2014

    Report

    Report Number
    1417592-2014-00001
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 5, 2013
    Report Date
    January 3, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THE INSERTION OF THE FOLEY CATHETER, THE CLINICIAN TESTED THE BALLOON BY INFLATING IT WITH 10 ML OF SALINE. IT APPARENTLY INFLATED AND DEFLATED WITHOUT ISSUE. SHE THEN INSERTED THE CATHETER AND ATTEMPTED TO INFLATE THE BALLOON. AFTER INSERTING 5 ML OF SALINE, SHE NOTICED A BULGING AT THE Y OF THE TUBING. SHE REMOVED THE CATHETER AND THEN INSERTED A NEW CATHETER WITHOUT FURTHER INCIDENT. THE SAMPLE WAS RETURNED AND EVALUATED. THE INFLATION LUMEN WAS FOUND TO BE COLLAPSED WHICH PREVENTED THE INFLATION OF THE BALLOON. THE ROOT CAUSE FOR THE COLLAPSE WAS NOT DETERMINED. WE PULLED SAMPLES FROM STOCK AND TESTED THEM. WE WERE UNABLE TO REPLICATE THE REPORTED ISSUE. THE BALLOONS WERE TESTED AND ALL INFLATED AND DEFLATED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE CATHETER BALLOON WOULD NOT INFLATE. A NEW CATHETER WAS THEN INSERTED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34467 SILICONE ELASTOMER COATED LATEX CATHETER TRAY NWR MEDLINE INDUSTRIES, INC. 13HB4297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other