BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOLEY SIL CATH 30ML 18CH X10

    MDR report key: 3671923 · Received February 25, 2014

    Report

    Report Number
    1282497-2014-00015
    Event Type
    Other
    Date Received
    February 25, 2014
    Date of Event
    January 12, 2014
    Report Date
    February 3, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Product Code
    EZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A FOLEY CATHETER. THE CUSTOMER REPORTS THE PATIENT IN QUESTION HAD TWO DAYS POST-OP FOLLOWING A RADICAL PROSTECTOMY. AT APPROX 1450 HOURS ON THE (B)(6) 2014, THE PATIENT'S WIFE REPORTED THAT THE CATHETER HAD COME OUT. WHEN THE NURSE WENT INTO THE ROOM, THE PATIENT HAD THE CATHETER IN HIS HAND. ON EXAMINATION OF THE CATHETER IT APPEARED THAT THE BALLOON HOLDING THE CATHETER IN SITU HAD BURST. RE-CATHETERIZATION WAS ATTEMPTED ON THE WARD BUT WAS UNSUCCESSFUL SO THE PATIENT WAS RETURNED TO THE THEATER FOR FLEXIBLE CYSTOSCOPY AND RE-INSERTION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115041 FOLEY SIL CATH 30ML 18CH X10 FOLEY CATHETER EZL COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 8887630187 13B164FHX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other