BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH FOLEY SIL ELSTMR 5CC 16FR

    MDR report key: 18185773 · Received November 21, 2023

    Report

    Report Number
    9611712-2023-00142
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Report Date
    February 14, 2024
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KOD
    UDI-DI
    10884521016163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE RECEIVED WAS PHYSICALLY INSPECTED. THE BALLOON WAS INFLATED WITH 10ML AS PER REQUIREMENT AND A BALLOON LEAK WAS CONFIRMED. THE CATHETER WAS INSPECTED UNDER DINOLITE CAMERA, AND A PINHOLE WAS FOUND AT THE BALLOON EDGE AREA. THIS PINHOLE WAS CAUSED BY THE WEAK BALLOON EDGE DUE TO THE LOW SDT VALUE FOR REINFORCEMENT LATEX LAYER. 100% INSPECTION FOR BALLOON WAS PERFORMED FOR ALL CATHETERS, HOWEVER THIS 100% INSPECTION USED AIR INFLATION METHOD NOT WATER INFLATION METHOD. THE PRESSURE EXERTED BY AIR WAS DIFFERENT THAN WATER. THUS, THIS DEFECT COULD NOT BE DETECTED DURING 100% INSPECTION. THIS LOT WAS MANUFACTURED AS PER DEFINED DEVICE MASTER RECORD. ALL ACCEPTANCE CRITERIA MET, AND THIS LOT WAS RELEASED MEETING ALL THE ACCEPTANCE CRITERIA. THE PINHOLE WAS CAUSED BY A WEAK BALLOON EDGE. THIS WEAK BALLOON EDGE WAS DUE TO THE LOW SDT VALUE OF REINFORCEMENT LATEX. NO CORRECTIVE/PREVENTATIVE ACTIONS (CAPA) WILL BE ESCALATED SINCE THE REPORTED ISSUE FALLS UNDER A RISK THAT WAS NOT A NEW HAZARD IDENTIFIED AND REDUCED OCCURRENCE FOR LATEX URINARY CATHETERS. A QUALITY ALERT WILL BE ISSUED FOR THIS TYPE OF COMPLAINT AND TO EMPHASIZE THE IMPORTANCE TO MONITOR THE SDT VALUE FOR THE LATEX. SECTION E1: THE INITIAL REPORTER ADDRESS HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    CUSTOMER REPORTS: THERE WAS AN A HOLE IN THE URINARY TUBE BALLOON THEREFORE IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. PER ADDITIONAL INFORMATION RECEIVED ON 11/21/23, THE HOLE WAS AT THE LEVEL OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925681 CATH FOLEY SIL ELSTMR 5CC 16FR CATHETER, UROLOGICAL KOD CARDINAL HEALTH 402716 3126S12QX 10884521016163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown