BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETER 2-WAY SILICONE 3CC 10FR

    MDR report key: 2193616 · Received July 13, 2011

    Report

    Report Number
    8040412-2011-00104
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A F/U REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: PER (B)(6) AFFILIATE: DR INSERTED THE URINARY CATHETER POST A CYSTOSCOPY-- TO DRAIN URINE AT 9.00 HRS AND THE NURSING STAFF ATTEMPTED TO REMOVE THE CATHETER AT 1800 HRS AND WAS UNABLE TO DEFLATE THE BALLOON AND REMOVE THE CATHETER FROM THE BLADDER. THEY CUT OFF THE VALVE AND WERE STILL UNABLE TO DEFLATE OR REMOVE THE CATHETER. THE DR WAS INFORMED AND THE DECISION WAS TAKEN TO TAKE THE PT BACK TO THEATRE (SURGERY) TO ATTEMPT TO REMOVE THE CATHETER. THE PT HAD TO RETURN TO THE THEATRE (SURGERY) TO HAVE THE CATHETER REMOVED UNDER ANESTHESIA BECAUSE THE PT WAS VERY TRAUMATIZED BY THE SEQUENCES OF EVENTS. CATHETER WAS REMOVED SUCCESSFULLY. PRODUCT HAS BEEN CUT IN A NUMBER OF PLACES TO FACILITATE THE REMOVAL OF THE CATHETER. NO PT INJURY REPORTED. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER 2-WAY SILICONE 3CC 10FR FOLEY CATHETER EZL TELEFLEX MEDICAL NA 10E08

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR