BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEADERFLEX

    MDR report key: 6629904 · Received June 9, 2017

    Report

    Report Number
    2245270-2017-00027
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    May 14, 2017
    Report Date
    July 11, 2017
    Manufacturer
    VYGON GMBH
    Product Code
    FOZ
    PMA / PMN Number
    K141026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT AND RETURNED SAMPLE HAVE BEEN SUBMITTED TO VYGON (B)(4), WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. VYGON (B)(4) REPORTS THE FOLLOWING REGARDING THIS COMPLAINT. THE CUSTOMERS' FINDINGS ARE CONFIRMED. THE RETURNED SAMPLE SHOWED A SEVERE KINK (90°) INSIDE THE CATHETER TUBE JUST DISTAL THE WING. THE CATHETER TUBE BURST AT THAT POINT. THE CATHETER SHOULD BE SUPPORTED TO AVOID CATHETER KINKING. FURTHER, ALCOHOL BASED DISINFECTANTS CAN WEAKEN THE CATHETER TUBE. VYGON HAS PROVIDED AN INFORMATION LEAFLET WITH SPECIAL HINTS IN THE PRODUCT'S IFU. THE LEAFLET STATES TO SECURE THE CATHETER TO THE SKIN AND DRESS THE INSERTION SITE AS PER HOSPITAL PROTOCOL. DO NOT EXPOSE TO ALCOHOL, ACETONE OR SOLVENT BASED DISINFECTANTS OR DRESSING SPRAYS. THIS IS THE FIRST COMPLAINT FOR BATCH NO. 040614GD AND THE FIRST FOR CODE 1212.04 CONCERNING A KINKED OR LEAKING CATHETER. AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION A MANUFACTURING FAULT COULD BE EXCLUDED. CORRECTIVE ACTION: NO CORRECTIVE ACTION AT THIS POINT. HOWEVER, BOTH VYGON GERMANY AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    CATHETER WAS KINKED & LEAKING AT THE CONNECTION TO CATHETER BELOW HUB, COULD SEE LEAKING ON OUTSIDE.

    Description of Event or Problem · 1

    CATHETER WAS KINKED AND LEAKING AT THE CONNECTION TO CATHETER BELOW HUB, COULD SEE LEAKING ON OUTSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412061 LEADERFLEX SHORT TERM CATHETER FOZ VYGON GMBH 040614GD

    Patients

    Seq Age Sex Outcome Treatment
    1