BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC PERITONEAL CATHETER, OPEN END W/ SLITS, STANDARD

    MDR report key: 4090608 · Received September 15, 2014

    Report

    Report Number
    2021898-2014-00370
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K792005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE RETURNED CATHETER WAS PATENT. IT ALSO MET REQUIREMENTS FOR THE LEAKAGE TEST. A FLOW SLIT WALL WAS OBSERVED TO BE DAMAGED ON THE CATHETER¿S LAST FLOW SLIT SET. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE STATES THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS. CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS, OR TEARS. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANTATION, THE CATHETER WAS FOUND TO HAVE A DAMAGED FLOW SLIT DURING THE PATENCY CHECK. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570407 CARDIAC PERITONEAL CATHETER, OPEN END W/ SLITS, STANDARD SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D41496

    Patients

    Seq Age Sex Outcome Treatment
    1