BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 100% SILICONE 2WAY PED 3CC 8FR 10/BX

    MDR report key: 2840182 · Received November 14, 2012

    Report

    Report Number
    8040412-2012-00185
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 6, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CUSTOMER ALLEGES: BALLOON CANNOT BE INFLATED. NO PT INJURY REPORTED. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH 100% SILICONE 2WAY PED 3CC 8FR 10/BX FOLEY CATHETER KOD TELEFLEX MEDICAL 12DE18

    Patients

    Seq Age Sex Outcome Treatment
    1