BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FEMALE CATH KIT

    MDR report key: 2018918 · Received March 11, 2011

    Report

    Report Number
    1018233-2011-00042
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 10, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    FFH
    PMA / PMN Number
    K905016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THERE IS NOTHING IN THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE FOR OBTAINING SPECIMENS STATES, "PULL CATHETER OUT OF TUBE TO DESIRED LENGTH. LAY TUBE ON STERILE FIELD. PROCEED WITH CATHETERIZATION. PULL CATHETER OUT OF TOP; TIGHTEN COVER AND DEPRESS BLUE SPOUT." THIS IS A USER-RELATED EVENT. THE USER FACILITY CONFIRMS THAT THE DEVICE WAS USED OFF-LABEL AND IS THE CAUSE OF THE EVENT. BARD HAS CONTACTED THE (B)(4) ON (B)(6) 2011 REGARDING THIS INCIDENT. (B)(4) HAS STATED THAT SHE WILL BE CONDUCTING A FACILITY-WIDE RETRAINING ON THE OFF-LABEL USE OF DEVICES. WE WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY ANY EMERGING TRENDS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY IN VISUALIZING THE URETHRA OF A FEMALE PT ON WHOM THEY OBTAINED URINE WITH A STRAIGHT CATHETER. THE PHYSICIAN ORDERED A TEMPERATURE FOLEY CATHETER. THE NURSE USED THE STRAIGHT CATHETER AS A GUIDE, INSERTING THE TEMPERATURE FOLEY CATHETER ABOVE THE STRAIGHT CATHETER TUBE. THE STRAIGHT CATHETER PASSED INTO THE PT'S BLADDER AND COULD NOT BE RETRIEVED BY THE RN. UROLOGY WAS CONSULTED AND A BEDSIDE FLEXIBLE CYSTOSCOPY WAS PERFORMED TO RETRIEVE THE STRAIGHT CATHETER WITHOUT ANY DIFFICULTY. THE PT TOLERATED THE PROCEDURE WELL AND REQUIRED NO ADDITIONAL STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FEMALE CATH KIT FFH C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention