BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC II EXTERNAL CSF DRAINAGE MGMT

    MDR report key: 157849 · Received March 19, 1998

    Report

    Report Number
    2132740-1998-00012
    Event Type
    Malfunction
    Date Received
    March 19, 1998
    Date of Event
    February 18, 1998
    Report Date
    February 19, 1998
    Manufacturer
    HEYER-SCHULTE NEUROCARE, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES THAT WEE EVALUATED WERE FROM THE HOSPITAL INVENTORY. THE MANUFACTURING DATES ARE ASSOCIATED WITH THE DEVICE INVENTORY THAT WAS EVALUATED. THERE WEE 11 DEVICES EVALUATED OF LOT NUMBER 1972967, MANUFACTURED 12/11/97. THERE WERE 3 DDEVICES EVALUATED OFLOT NUMBER 1972747, MANUFACTURED 11/17/97. THE DEVICES WEE FUNCTIONALLY TESTED PRIOR TO THE TORQUE TEST. ALL PRODUCTS WERE FOUND TO FUNCTION PER SPECIFICATION. A TORQUE TEST WAS PERFORMED ON ALL DEVICES TO TEST THE STRENGTH OF THE MOLDED PORT. THE TORQUE TEST REVEALED THAT THE BURETTE CHAMBER PORT WOULD ALLOW FOR THE 5 LB. DESIGN SPECIFICATION. WALL THICKNESS WAS ANALIZED BY MEASUREMENT OF 3 POINTS OF THE BURETTE PORT. DIMENSIONS WERE WITHIN SPECIFICATION AT THE TIME OF MANUFACTURE. CUSTOMER CLAIMS: FAILURE INVESTIGATION HAS BEEN REQUESTED OF CO ENGINEERING. RESPONSE: VISUAL SHOWED 14 UNITS WERE RECEIVED IN THEIR ORIGINAL PACKAGES COMPLETELY SEALED. UNITS WERE OPENED AND INSPECTED UNDER MICROSCOPE AND DID NOT REVEAL ANY CRAZING OR MOLDING BUBBLES. AS TO THE TORQUE TEST AND COMPARING TO UNBONDED TIPS. THE WALL THICKNESS IS IN PROCESS AS SOON AS THE RESULTS ARE DONE, THEY WILL BE INFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS IN SURGERY FOR A CRANIOTOMY. A VENTRICULAR DRAIN WAS PLACED AND UPON THE ARRIVAL OF THE PT IN ICU IT WAS FOUND THAT THE BOTTOM OF THE BURETTE CHAMBER OF THE DRAINAGE SYSTEM HAD BROKEN OFF. THE CONTENTS OF WHICH CONTAINED BLOOD, HAD SPILLED. THERE WAS NO PT INJURY INVOLVED, HOWEVER, THE NURSE REPORTED THAT THERE WAS A POTENTIAL FOR CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMETIC II EXTERNAL CSF DRAINAGE MGMT Implant EXTERNAL VENTRICULAR DRAINAGE SYSTEM JXG HEYER-SCHULTE NEUROCARE, INC. NL850-8300N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA