BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD LATEX FREE SILICONE CATH KIT

    MDR report key: 111114 · Received July 29, 1997

    Report

    Report Number
    MW1011832
    Event Type
    Malfunction
    Date Received
    July 29, 1997
    Date of Event
    July 21, 1997
    Report Date
    July 25, 1997
    Manufacturer
    BARD UROLOGICAL DIVISION, C.R. BARD, INC.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD BARD SILICONE 16 FR. FOLEY INSERTED 7/20/97 0630. FOLEY REMOVED 7/21 0615. PT COMPLAINED OF A GREAT DEAL OF PAIN AND NURSE STATED HAD DIFFICULTY REMOVING THAT LAST 2-3 INCHES. BALLOON HAD BEEN DEFLATED WITHOUT DIFFICULTY, RN NOTED A HARD RIDGE AT BALLOON SITE AFTER REMOVAL AND REPORTED IT TO NURSING ADMINISTRATION. SAFETY OFFICER OBTAINED A CLEAN FOLEY CATH KIT AND INFLATED THE BALLOON AS REQUIRED. SAFETY OFFICER LEFT THE BALLOON INFLATED FOR 24 HR. SAME AS PT. WHEN SAFETY OFFICER DEFLATED THE BALLOON THE NEXT DAY, THE DEFLATED BALLOON LEFT A HARDRIDGE AROUND THE CATHETER, WHICH COULD CAUSE DISCOMFORT UPON REMOVAL, ESPECIALLY IN A MALE WHO MAY HAVE ANY TYPE OF STRICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD LATEX FREE SILICONE CATH KIT FOLEY CATHETER WITH GRAVITY DRAINAGE BAG KOD BARD UROLOGICAL DIVISION, C.R. BARD, INC. * 76LF2515

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other IV THERAPY, ANTIBIOTICS, COLOSTOMY