BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER

    MDR report key: 3851171 · Received May 23, 2014

    Report

    Report Number
    1018233-2014-00114
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    January 8, 2014
    Report Date
    April 28, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE A 16 FRENCH FOLEY CATHETER WAS PLACED. RESISTANCE WAS MET UPON INSERTION, THE CATHETER WAS NOT FORCED INTO THE PATIENT. A SECOND ATTEMPT WAS MADE TO INSERT THE CATHETER; HOWEVER, WHEN THE PHYSICIAN PULLED BACK ON THE CATHETER BLOOD FILLED THE CATHETER AND BAG (ABOUT 12 INCHES). IT WAS THEN CONFIRMED THAT THE PATIENT EXPERIENCED A URETHRAL TEAR. A 16 FRENCH COUDE TIP CATHETER WAS PLACED WITHOUT FURTHER IMPACT TO THE PATIENT. CLEAR URINE WAS RETURNED. THE FOLEY CATHETER WAS LEFT IN PLACE FOR THE URETHRA TO HEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309060 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention