BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H/S CATHETER SET 7 FRENCH

    MDR report key: 3243180 · Received July 18, 2013

    Report

    Report Number
    1216677-2013-00024
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 15, 2013
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE H/S CATHETER WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO NON-CONFORMITIES. A REVIEW OF THE COMPLAINT HISTORY SHOWED NO TREND. EIGHT UNITS WERE FOUND IN FINISHED GOOD INVENTORY FROM THE SAME LOT NUMBER. ALL UNITS WERE VISUALLY INSPECTED AND NO ABNORMALITIES WERE NOTED. TWO OF THE EIGHT UNITS WERE FUNCTIONALLY TESTED BY QUALITY AND MANUFACTURING ENGINEERING AND BOTH UNITS INFLATED AND DEFLATED WITHOUT ISSUE. THE NON-CONFORMANCE COULD NOT BE VERIFIED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF THE EXAMINATION THE BALLOON ON THE CATHETER WOULD NOT DEFLATE, EVENTUALLY IT HAD TO BE BURST WITH A NEEDLE. THE PATIENT WAS IN A LOT OF PAIN AS THE CATHETER WOULD NOT COME OUT. DR (B)(6) ADMINISTERED BUSCOPAN AS THE WOMB HAD GONE INTO SPASM, SHE ALSO GAVE THE PATIENT VOLTEROL SUPPOSITORY WHICH SHE WOULD NORMALLY NOT DO BUT THE PATIENT WAS IN SO MUCH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335302 H/S CATHETER SET 7 FRENCH NONE GEH COOPERSURGICAL, INC. 130214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R