BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETERS

    MDR report key: 3970605 · Received June 2, 2014

    Report

    Report Number
    9611710-2014-00139
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K841544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THEY REMOVED THE CATHETER AND CHANGED TO ANOTHER NEW ONE. ADD'L INFO WAS REQUESTED ON (B)(4) 2014. A QUALITY EVAL WAS PERFORMED ON (B)(4) 2014. ONE USED SIZE 20X30 3 WAY STANDARD SEC FOLEY CATHETER OF OPAQUE QUALITY. PRODUCT FITTED WITH BESPAK VALVE YELLOW PREPRINTED SHRINK SLEEVE CARRYING INFO AS PER UNOMEDICAL SPEC. PRODUCT SHOWED NO SIGN OF MATERIAL DEGRADATION OR DISCOLORATION. THE PRODUCT WAS TESTED ON (B)(4) 2014. NOTE: COMPLAINANT REPORTED THE PRODUCT CODE (B)(4) AND LOT#408270R002 SIZE 22X30 BUT, THE ACTUAL PRODUCT RECEIVED IS SIZE 20X30 WITH NO LOT NUMBER. PRODUCT WAS EXAMINED, BALLOON HAD BURST UPON RECEIPT. REVIEW OF THE BALLOON UNDER MAGNIFICATION REVEALED THERE WERE SEVERAL PUNCTURES ON THE BALLOON SLEEVE MOST PROBABLY CAUSED BY A SHARP OR POINTED OBJECT. REVIEW OF THE INSPECTION BATCH RECORD DID NOT REVEAL ANY BURST BALLOON WAS DETECTED DURING INSPECTION. REVIEW OF THE IN-PROCESS FUNCTIONAL TEST REPORT FOR DIP CODES (B)(4) (DIPPED IN (B)(4) 2013) DID NOT REVEAL ANY SIGNS OF SUCH DEFECT DETECTED DURING THE FUNCTIONAL TEST. SAMPLES TAKEN FROM THIS MFG LOT MET THE SPEC WHEN SUBJECTED FOR THE FUNCTIONAL TEST IN ACCORDANCE TO (B)(4). REVIEW OF THE RISK ASSESSMENT FILE DID COVER A FEW POTENTIAL CAUSES AND IT'S CONTROLLED. REVIEW OF THE COMPLAINT TREND WITHIN YEAR 2009 TO YTD (B)(4) 2014 FOR THE BURST BALLOON ISSUE, STATISTICALLY THERE IS NO SIGNIFICANT NEGATIVE TRENDING OBSERVED. BASED ON THE INVESTIGATION FINDING, BALLOON BURST COULD PROBABLY BEEN DUE TO PUNCTURE ON THE BALLOON SLEEVE MOST PROBABLY CAUSED BY SHARP OR POINTED OBJECT THAT MAKES THE BALLOON TO BECOME WEAK AND CAUSE IT TO RUPTURE UPON STRESS, IE. WHEN INFLATED AND INDWELLED IN THE BLADDER FOR SOME TIME. BASED ON COMPLAINT TRENDING, STATISTICALLY THERE IS NO SIGNIFICANT NEGATIVE TRENDING. THUS, NO FURTHER EVAL NEEDED AND COMPLAINT CAN BE CONSIDERED CLOSED. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "BALLOON BURST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320926 FOLEY CATHETERS CATHETER, RETENTION TYPE, BALLOON, 78EZL EZL UNOMEDICAL SDN BHD MM55162230 408270R002

    Patients

    Seq Age Sex Outcome Treatment
    1