BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 3778308 · Received April 23, 2014

    Report

    Report Number
    9611710-2014-00064
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    December 13, 2013
    Report Date
    March 24, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    EZL
    PMA / PMN Number
    K945806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A SERIOUS INJURY. THE COMPLAINANT REPORTED THAT THE CATHETER HAD BEEN CLAMPED TO INCREASE THE PRESSURE IN THE BLADDER DURING SURGERY. IT WAS FURTHER REPORTED THAT THE CATHETER BALLOON WAS EMPTIED USING A GUIDE WIRE THROUGH THE BLADDER WALL AND THE CATHETER WAS DISCONTINUED. A QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. NO SAMPLE WAS RECEIVED FROM CUSTOMER. ONLY THE PRODUCT LOT #407044R001 AND CATALOG #MM51121410 WAS AVAILABLE TO ASSIST IN RECORD REVIEW. REVIEW OF THE ASSEMBLY WORK ORDER DID NOT REVEAL ANY SIGNS OF SLOW DEFLATION AND COLLAPSED AIRLINE DETECTED DURING THE INSPECTION. A REVIEW OF THE PAST TWO YEARS (2012-2013) COMPLAINT HISTORY RECORDS REVEALED THAT THERE WAS SMALL PERCENTAGE OF THE COMPLAINTS RELATED TO NON-DEFLATION ARE MANUFACTURING RELATED. CORRECTIVE ACTIONS HAVE BEEN TAKEN TO ADDRESS THE CONFIRMED COMPLAINT CASES. THERE ARE A FEW OTHER POTENTIAL CAUSES WHICH HAVE BEEN IDENTIFIED AS HAZARD DURING RISK MANAGEMENT PROCESS AND SUCH RISKS ARE CONTROLLED TO MINIMAL. REVIEW OF THE IN-PROCESS FUNCTIONAL TEST REPORT FOR DIP CODES (QKD, QKE, QLA AND QLD -DIPPED IN FEBRUARY 2013) DID NOT REVEAL ANY SIGNS OF SUCH DEFECT DETECTED DURING THE DRAINAGE TEST. SAMPLES TAKEN FROM THIS MANUFACTURING LOT MET THE SPECIFICATIONS WHEN SUBJECTED FOR THE FUNCTIONAL TEST IN ACCORDANCE TO EN1616 TEST METHOD. THE COMPLAINT SAMPLE IS NOT EXPECTED TO BE AVAILABLE FOR EVALUATION. BASED ON THE HISTORY RECORD REVIEW, IT DID NOT SHOW ANY SIGNIFICANT ABNORMALITIES. SINCE THE ACTUAL PRODUCT WAS NOT RETURNED, FURTHER INVESTIGATION IN DETERMINING AND CONFIRMING THE ROOT CAUSE OF PRODUCT FAILURE COULD NOT BE CARRIED OUT. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON AP(B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPLAINANT STATED THAT THE DEVICE WAS USED AT A RECTUM SURGERY. AFTER SURGERY, THE FOLEY CATHETER BALLOON COULDN'T BE EMPTIED WHEN TRYING TO REMOVE THE CATHETER. SEVERAL WAYS OF EMPTYING THE BALLOON WAS TRIED (WITH SYRINGE, WITH SYRINGE WITH NEEDLE). FINALLY THE CATHETER WAS REMOVED BY PUNCTURING THE BALLOON USING A GUIDE WIRE THROUGH THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245337 FOLEY CATHETER EZL UNOMEDICAL SDN BHD MM51121410 407044R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention