BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 2W STD SIL CH16

    MDR report key: 2932402 · Received January 24, 2013

    Report

    Report Number
    9611710-2013-00015
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    September 19, 2011
    Report Date
    September 19, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    MJC
    PMA / PMN Number
    K770256
    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). THIS IS RELATED TO (FDA AUDIT-OBSERVATION #7 FROM (B)(4)). BASED ON AVAILABLE INFORMATION, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: BECAUSE SOMETIMES, A SURGICAL INTERVENTION IS NEEDED TO REMOVE A CATHETER WHOSE BALLOON FAILS TO DEFLATE. REPORTED TO THE FDA ON JANUARY 23, 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THIS COMPLAINT WAS RECEIVED BY (B)(4) ON (B)(6) 2011 FROM (B)(6) FOR PRODUCT 2 WAY STANDARD SEC FOLEY CATHETER SIZE 18X10. CUSTOMER COMPLAINING: "IMPOSSIBLE TO DEFLATE BALLOON". AFTER 29 DAYS INDWELLED, IT WAS IMPOSSIBLE TO DEFLATE. THEN SHAFT WAS CUT AND THE BALLOON WAS DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33840 FOLEY CATHETER, 2W STD SIL CH16 UROLOGICAL CATHETER AND ACCESSORIES MJC UNOMEDICAL SDN BHD E210-18TN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R