BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER

    MDR report key: 1732318 · Received January 22, 2010

    Report

    Report Number
    1220948-2009-00013
    Event Type
    Malfunction
    Date Received
    January 22, 2010
    Date of Event
    November 4, 2009
    Report Date
    January 14, 2010
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    GBZ
    PMA / PMN Number
    K030041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MFG DATE 01/2008. DEVICE #2: LOT# RST1251, MFG DATE 01/2008, EXP DATE 01/2010. DEVICE #3: LOT# RST1255, MFG DATE 08/2007, EXP DATE 06/2010. DEVICE #4: LOT # RED1286, MFG DATE 07/2009, EXP DATE 05/2012 - NO PROBLEM FOUND. AN MDR DECISION TREE FOR COMPLAINT REPORTING WAS REVIEWED AND ALL DEVICES COMPLAINTS ARE NOT CONSIDERED TO BE REPORTABLE. THE MALFUNCTIONS WERE FOUND WHEN COMPLAINT DEVICES WERE EVALUATED BY THE HOSP DURING THE PRE-USE CHECK. A PRE-USE CHECK IS A REQUIREMENT IN THE IFU. THE DEVICES WERE RETURNED FOR EVAL. WE WERE ABLE TO CONFIRM THE FAILURE FOR THE LOT NUMBERS RST1305, RST1251, RST1255. THERE WAS NO PROBLEM FOUND FOR THE LOT #RED1286. THE ROOT CAUSE OF MALFUNCTIONS IS INCONCLUSIVE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL MFG AND QUALITY INSPECTIONS WERE COMPLETED IN ACCORDANCE TO THE INSTRUCTIONS. PLEASE NOTE THAT NO PT INJURIES HAPPENED.

    Description of Event or Problem · 1

    FOUR CHOLANGIOGRAM CATHETERS WERE DEFECTIVE. THE BALLOONS WOULD NOT INFLATE, OR BROKE WHEN THEY DID. DEVICES WERE NOT USED IN PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDDICK SCOOP TIP CHOLANGIOGRAM CATHETER CHOLANGIOGRAM CATHETER GBZ LEMAITRE VASCULAR RST1305

    Patients

    Seq Age Sex Outcome Treatment
    1