BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 WAY STANDARD SIL FOLEY CATHETER

    MDR report key: 4232319 · Received July 7, 2014

    Report

    Report Number
    9611710-2014-00178
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. ADD'L INFO RECEIVED VIA EMAIL ON 06/20/2014 STATING "THERE WAS NO CLINICAL RISK TO THE PT ONLY PROLONGED PROCEDURE TO CHANGE THE DEVICE. THE PT'S CONDITION (I.E. BLADDER CONTRACTION) WAS, ACCORDING TO THE END USER, THE CAUSE OF NON-DEFLATION OF THE BALLOON. NEVERTHELESS THE MEDICAL STAFF FAILED INITIALLY TO DEFLATE BY CUTTING THE FUNNEL BUT THEN SUCCEEDED BY INSERTING A FINE GUIDE WITHIN THE INFLATION WHICH ENABLED TO PIERCE THE BALLOON FOR SUCCESSFUL CATHETER WITHDRAWAL". NO SAMPLE WAS RECEIVED FROM CUSTOMER. ONLY THE PRODUCT LOT# 407455R001, CAT# HA14141002 WAS AVAILABLE TO ASSIST IN RECORD REVIEW. REVIEW OF ASSEMBLY WORK ORDER DID NOT REVEAL ANY SIGNS OF NON-DEFLATION DETECTED DURING THE INSPECTION. REVIEW OF THE COMPLAINT TREND FROM 2009 TO YTD MAY 2014, THERE IS NO SIGNIFICANT NEGATIVE TREND WAS OBSERVED. REVIEW OF THE IN-PROCESS FUNCTIONAL TEST REPORT FOR TIP CODEX OXL DIPPED IN MAY 2013 DID NOT REVEAL ANY SIGN OF SUCH DEFECT DETECTED DURING THE DRAINAGE TEST. THE SAMPLES TAKEN FROM THIS MFG LOT MET THE SPEC WHEN SUBJECTED FOR THE FUNCTIONAL TEST IN ACCORDANCE TO (B)(4) TEST METHOD. REVIEW OF THE RISK ASSESSMENT FILE DOES COVER POTENTIAL CAUSE AND IT'S CONTROLLED. ACTUAL ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS THE COMPLAINT SAMPLE IS NOT EXPECTED TO BE AVAILABLE FOR EVAL. BASED ON RECORD REVIEW DID NOT SHOW ANY SIGNIFICANT ABNORMALITIES. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A F/U REPORT WILL BE SUBMITTED. REPORTED TO FDA ON JULY 07, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED "BALLOON DID NOT DEFLATE PROBABLY DUE TO SIGNIFICANT CONTRACTIONS OF THE BLADDER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393187 2 WAY STANDARD SIL FOLEY CATHETER CATHETER, RETENTION TYPE, BALLOON EZL UNOMEDICAL SDN BHD HA14141002 407455R001

    Patients

    Seq Age Sex Outcome Treatment
    1