BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER

    MDR report key: 5108647 · Received September 28, 2015

    Report

    Report Number
    1018233-2015-00357
    Event Type
    Injury
    Date Received
    September 28, 2015
    Report Date
    September 2, 2015
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "TO DEFLATE CATHETER BALLOON: GENTLY INSERT A SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. ALLOW THE BALLOON TO DEFLATE SLOWLY ON ITS OWN. DO NOT ASPIRATE OR MANUALLY ACCELERATE THE DEFLATION OF THE BALLOON. IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. DEVICE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON REMOVAL, THE CATHETER DEVELOPED A CUFF ROLL. THE PATIENT ALLEGEDLY EXPERIENCED TRAUMA, EXCRUCIATING PAIN AND A PROLONGED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638128 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention