BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SLC CH16

    MDR report key: 2935143 · Received January 28, 2013

    Report

    Report Number
    9611710-2013-00032
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K944007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON COMPLAINTS FROM OUR FACILITY IN (B)(4). BASED ON AVAILABLE INFO, OUR MED DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON HAS FAILED TO DEFLATE. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REC'D BY (B)(4) ON (B)(6) 2012 FROM (B)(6) FOR PRODUCT 2 WAY STANDARD SLC FOLEY CATHETER SIZE 16X10. CUSTOMER COMPLAINING: "NON DEFLATION". TWO WEEKS AFTER INSERTION OF THE CATHETER, THEY TRIED TO DRAIN WATER FROM THE BALLOON BUT THEY COULD NOT. THEY CUT THE Y-PART, BUT THEY COULD NOT DRAIN WATER. THEN THEY CUT 3CM OF SHAFT. THEY COULD DRAIN WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37920 FOLEY CATHETER, 2W STD SLC CH16 UROLOGICAL CATHETER AND ACCESSORIES EZL UNOMEDICAL SDN BHD HY210-16JN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention