BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETERS

    MDR report key: 3824461 · Received May 8, 2014

    Report

    Report Number
    9611710-2014-00103
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K841544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. A QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. NO SAMPLE WAS RECEIVED FROM CUSTOMER. ONLY THE PRODUCT LOT # 407382R001 AND CATALOG # HA31181002 WAS AVAILABLE TO ASSIST IN RECORD REVIEW. REVIEW OF THE ASSEMBLY WORK ORDER DID NOT REVEAL ANY SIGNS OF NON-DEFLATION DETECTED DURING THE INSPECTION. REVIEW OF PAST TWO YEARS (2012-2013) COMPLAINT HISTORY RECORD REVEALED THAT THERE WAS A SMALL PERCENTAGE OF THE COMPLAINT RELATED TO NON-DELATION ARE MANUFACTURING RELATED. CORRECTIVE ACTIONS HAVE BEEN TAKEN TO ADDRESS THE CONFIRMED COMPLAINT CASES. THERE ARE A FEW OTHER POTENTIAL CAUSES IDENTIFIED AS HAZARDS DURING THE RISK MANAGEMENT PROCESS AND SUCH RISKS ARE CONTROLLED TO MINIMAL. REVIEW OF THE IN-PROGRESS FUNCTIONAL TEST REPORT FOR DIP CODES (OID, OJC AND OJD) DIPPED IN (B)(4) 2012, DID NOT REVEAL ANY SIGNS OF SUCH DEFECT DETECTED DURING THE DRAINAGE TEST. THE SAMPLES TAKEN FROM THIS MANUFACTURING LOT MET THE SPECIFICATION WHEN SUBJECTED FOR THE FUNCTIONAL TEST IN ACCORDANCE TO (B)(4) TEST METHOD. ACTUAL ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS THE COMPLAINT SAMPLE IS NOT EXPECTED TO BE AVAILABLE FOR EVALUATION. BASED ON HISTORY REVIEW DID NOT SHOW ANY SIGNIFICANT ABNORMALITIES. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE BALLOON HAS NOT DEFLATED. TO DEFLATE IT, THE RADIOLOGIST CUT THE CATHETER ABOVE THE FUNNEL, WITHOUT SUCCESS. THEN, HE INSERTED A SMALL RIGID GUIDE IN THE BODY OF THE CATHETER. AFTER SEVERAL MANIPULATIONS USING THE GUIDE AND THE SYRINGE, DURING APPROXIMATELY ONE HOUR, THE BALLOON HAS BEEN DEFLATED. THE CATHETER HAS BEEN USED DURING A RADIOLOGICAL EXAMINATION WHICH USUALLY LASTED ABOUT 15 MINUTES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278226 FOLEY CATHETERS CATHETER, RETENTION TYPE, BALLOON EZL UNOMEDICAL SDN BHD HA31181002 407382R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention