BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYSTERO PUMP TUBE SET

    MDR report key: 966447 · Received December 20, 2006

    Report

    Report Number
    1418479-2006-00025
    Event Type
    Malfunction
    Date Received
    December 20, 2006
    Date of Event
    August 14, 2006
    Report Date
    November 20, 2006
    Manufacturer
    W.O.M. WORLD OF MEDICINE AG
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (1) 4170.223 - TUBE SET. THIS IS A STERILE TUBE SET THAT IS DISTRIBUTED 10 EACH PER PACKAGE. THE TUBE SET WAS INSPECTED FOR ANY ABNORMALITIES, SPECIFICALLY SHARP EDGES. THERE WERE NO SHARP EDGES FOUND. THE TUBE SET WAS USED TO SET UP ON A HYSTEROSCOPE PUMP AT OUR FACILITY. THE WHITE CLAMP FIT CORRECTLY ONTO THE PUMP. CAUSE OF EVENT: PRODUCT WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE WAS TRYING TO PUT THE TUBING THROUGH THE PUMP. THE WHITE CLAMP THAT GOES INTO THE MACHINE HAD AN EDGING COMING UP ON IT. IT WOULD NOT FIT INTO THE MACHINE, AS IT IS SUPPOSE TO AND COULD NOT BE USED. ANOTHER TUBING WAS OPENED AND USED WITHOUT A PROBLEM. DEVICE USAGE PROBLEM: OTHER. INFO FROM ENDUSER STATED, THAT THERE IS A POTENTIAL FOR THE HEALTH CARE PROVIDER TO GET A PINCH ON THE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYSTERO PUMP TUBE SET TUBE SET HIH W.O.M. WORLD OF MEDICINE AG 4170.223 050443

    Patients

    Seq Age Sex Outcome Treatment
    1 *