BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UMBILICAL CATHETER

    MDR report key: 11338516 · Received February 17, 2021

    Report

    Report Number
    2245270-2021-00014
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    July 30, 2020
    Report Date
    April 27, 2021
    Manufacturer
    VYGON
    Product Code
    FOS
    PMA / PMN Number
    K981630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE 510K NUMBER SHOULD BE K981630. THE PREVIOUS INITIAL REPORT MDR-2245270-2021-00014 LISTED K921352 ERRORONEOUSLY.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN FRANCE FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED AN UMBILICAL CATHETER; A LARGE AMOUNT OF DRIED BLOOD / DRUG IS PRESENT IN THE CATHETER. THE SUTURE IS WRAPPED AROUND THE TUBE AT MARK 10 INDICATES THAT THE PRODUCT WAS DAMAGED DURING THE DRESSING CHANGE. THE TUBE IS DETACHED FROM THE GREEN HUB. AFTER CUTTING THE GREEN HUB, THE GLUE IS VISIBLE ON PART OF THE PERIPHERY OF THE END. A REVIEW OF THE BATCH FILE DID NOT REVEAL ANY ANOMALIES DURING PRODUCTION ON THIS BATCH. THE TIGHTNESS AND NON-TIGHTNESS CHECKS CARRIED OUT AT 100% MEET OUR REQUIREMENTS. TENSILE TESTS DURING PRODUCTION ALSO MEET OUR SPECIFICATIONS. WE HAVE REGISTERED A SIMILAR COMPLAINT ON THIS CODE ALSO DUE TO A TEARING OFF. (DEFECT RELATED TO THE CONDITIONS OF USE). AS THE TUBE HELD FOR 4 DAYS, WE DO NOT BELIEVE THIS IS RELATED TO MANUFACTURING DEFECT THEREFORE, NO FURTHER CORRECTIVE ACTION IS INITIATED BY QUALITY MANAGEMENT. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THIS ISSUE COULD NOT BE TRACED TO MANUFACTURING DEFECT; THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    CATHETER NOT INTACT. REMOVED WITH DIFFICULTY. CATHETER BROKEN AT GREEN COLORED HUB.

    Description of Event or Problem · 0

    CATHETER NOT INTACT. REMOVED WITH DIFFICULTY. CATHETER BROKEN AT GREEN COLORED HUB.

    Additional Manufacturer Narrative · 1

    THE FAILED DEVICE WAS RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE REPORTED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    CATHETER NOT INTACT. REMOVED WITH DIFFICULTY. CATHETER BROKEN AT GREEN COLORED HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233861 UMBILICAL CATHETER UMBILICAL CATHETER FOS VYGON 1272.14 140819EJ

    Patients

    Seq Age Sex Outcome Treatment
    1