BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH FOLEY CATHETER, PEDIATRIC, 6FR, 100%SIL.

    MDR report key: 1944290 · Received December 6, 2010

    Report

    Report Number
    8040412-2010-00109
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 11, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN REC'D BY MFR, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TIP SNAPPED ON THE CATHETER WHILE IN SITU. PT NEEDED TO BE RE-CATHETERIZED. ADD'L INFO REC'D ON 12/02/2010, STATED THAT THE TIP OF THE CATHETER REFERS TO THE FUNNEL END OF THE CATHETER, WHICH IS THE EXTERIOR PORTION NOT IN THE BODY CAVITY. THERE WERE NO ISSUES WHEN REMOVING THE CATHETER. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH FOLEY CATHETER, PEDIATRIC, 6FR, 100%SIL. PEDIATRIC FOLEY CATHETER KOD TELEFLEX MEDICAL NA 10GE27

    Patients

    Seq Age Sex Outcome Treatment
    1