BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET

    MDR report key: 20257805 · Received September 19, 2024

    Report

    Report Number
    2245270-2024-00077
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    August 26, 2024
    Report Date
    January 10, 2025
    Manufacturer
    VYGON USA
    Product Code
    FPB
    PMA / PMN Number
    K894954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE TWO (2) OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2024-00076. 2245270-2024-00077. THE COMPLAINT AND RETURNED SAMPLES HAVE BEEN SUBMITTED TO VYGON COLOMBIA, WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. THE SUPPLIERS REPORT THE FOLLOWING REGARDING THIS COMPLAINT. THE SAMPLES INVOLVED WERE RECEIVED AND IT WAS OBSERVED THAT THE MLL FITTING HAD FALLEN OFF. THE EXTERNAL DIAMETER OF THE TUBE WITH THE MLL FITTING WERE MEASURED, IT WAS EVIDENT THAT THERE WAS A TRACE OF GLUE, AND THAT THE ASSEMBLY WAS MADE AT THE CORRECT LENGTH DUE TO THE EXISTING MARKING ON THE TUBE. THE MEASUREMENTS OF RETURNED UNUSED DEVICES WERE ALSO CHECKED, AND THE EXTERNAL DIAMETERS OF THE TUBES WERE FOUND TO BE WITHIN SPECIFICATIONS. THEREFORE, VYGON COLOMBIA BELIEVES THAT THE SEPARATION OF THE TUBING IS DUE TO THE TUBING BEING OUT OF TOLERANCE. VYGON COLOMBIA'S DOCUMENT REVIEW FOUND NO NONCONFORMITIES DURING THE MANUFACTURING PROCESS. A TWO-YEAR REVIEW OF VYGON USA'S COMPLAINTS DATA FOUND THREE COMPLAINTS RELATED TO LEAKING/TUBING SEPARATION FOR THE AMS-427 PRODUCT, ALL OF WHICH ORIGINATED FROM THIS FACILITY. CORRECTIVE ACTION: BASED ON VYGON COLOMBIA'S INVESTIGATION, THE POSSIBLE CAUSE OF THE TUBING SEPARATION IS RELATED TO THE TUBING ID DIMENSIONS. AS A RESULT, VYGON USA IS CONDUCTING A STUDY TO ASSESS CHANGES IN TUBING DIMENSIONS AND TOLERANCES TO CREATE SUCCESSFUL BOND FOR FLL AND MLL LUERS. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THERE WERE TWO (2) OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2024-00076. THE FAILED DEVICES WILL BE RETURNED TO VYGON 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 · 0

    EXTENSION SET IS BREAKING/SEPARATING AT MULTIPLE POINTS ALONG THE SET.

    Description of Event or Problem · 0

    EXTENSION SET IS BREAKING/SEPARATING AT MULTIPLE POINTS ALONG THE SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746498 ADMINISTRATION SET INFUSION LINE FPB VYGON USA AMS-427 220623BA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown