BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHYSA

    MDR report key: 7450700 · Received April 23, 2018

    Report

    Report Number
    3001587388-2018-18150
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    March 16, 2018
    Report Date
    July 19, 2018
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K853362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OUR MANUFACTURING FACILITY FOR QUALITY CONTROL ANALYSIS. THE CATHETER THAT WAS RECEIVED DID NOT DISPLAY THE DEFECT OBSERVED BY THE USER. THE STYLET DELIVERED WITH THE CATHETER TO OPEN ITS END WENT THROUGH THE OPENING WITHOUT ADHESION. A REVIEW OF THE FABRICATION RECORD FOR THE LOT OF CATHETERS SHOWED NO ANOMALIES. IN CONCLUSION, THE CATHETER COMPLIES WITH ITS SPECIFICATION. THE DEFECT REPORTED BY THE USER COULD NOT BE REPRODUCED UNDER LABORATORY CONDITIONS.

    Description of Event or Problem · 0

    DURING A DEMONSTRATION, OUR SALES REPRESENTATIVE IN THE US OPENED A STERILE CATHETER, FOR THE PURPOSE OF DEMONSTRATING THE PRODUCT. WHILE INSPECTING THE PRODUCT, IT BECAME APPARENT THAT THE PROXIMAL TIP OF THE CATHETER WAS EITHER NOT PRE-CUT, OR INSUFFICIENTLY PRE-CUT. THE STYLET COULD NOT PASS THROUGH THE PROXIMAL TIP OF THE CATHETER, WHICH SHOULD BE POSSIBLE, AS THIS CATHETER REFERENCE IS DESIGNED FOR ENDOSCOPIC PROCEDURES, IN WHICH A FLEXIBLE ENDOSCOPE WOULD BE PASSED THROUGH THE TIP. THIS OCCURED WITHIN HEAD OFFICE WAREHOUSE INVENTORY, NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 1

    DURING A DEMONSTRATION, OUR SALES REPRESENTATIVE IN THE US OPENED A STERILE CATHETER, FOR THE PURPOSE OF DEMONSTRATING THE PRODUCT. WHILE INSPECTING THE PRODUCT, IT BECAME APPARENT THAT THE PROXIMAL TIP OF THE CATHETER WAS EITHER NOT PRE-CUT, OR INSUFFICIENTLY PRE-CUT. THE STYLET COULD NOT PASS THROUGH THE PROXIMAL TIP OF THE CATHETER, WHICH SHOULD BE POSSIBLE, AS THIS CATHETER REFERENCE IS DESIGNED FOR ENDOSCOPIC PROCEDURES, IN WHICH A FLEXIBLE ENDOSCOPE WOULD BE PASSED THROUGH THE TIP. THIS OCCURED WITHIN HEAD OFFICE WAREHOUSE INVENTORY, NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295871 SOPHYSA ENDOSCOPIC RIGHT ANGLE, ANTI-BLOK VENTRICULAR CATHETER WITH RESERVOIR, 7 CM JXG SOPHYSA SRS07 E0751

    Patients

    Seq Age Sex Outcome Treatment
    1