BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEC 20DP, TEXIUM & HANGER V/NV

    MDR report key: 12264621 · Received August 3, 2021

    Report

    Report Number
    9616066-2021-51686
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    June 23, 2021
    Report Date
    September 15, 2021
    Product Code
    FPA
    UDI-DI
    50885403225626
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2021-08-20. INVESTIGATION: H.6. INVESTIGATION SUMMARY: ONE USED TEXIUM SECONDARY SET, MODEL 40000-07T, WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD BE OBSERVED THAT THE SET'S DRIP CHAMBER WAS DISCONNECTED FROM THE TUBING. NO OTHER DEFECTS WERE OBSERVED. THE CUSTOMER'S COMPLAINT THAT THE LINE DETACHED FROM BELOW THE DRIP CHAMBER WAS VERIFIED. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON BOTH THE INTERNAL AND EXTERNAL TUBING ENGAGEMENT COMPONENTS. IT COULD BE IDENTIFIED THAT THE SOLVENT HAD NOT BEEN PROPERLY APPLIED TO THE TUBING DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 40000-07T BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE POTENTIAL ROOT CAUSE FOR THE LACK OF SOLVENT WAS FOUND TO BE: 1. UNDEFINED SCREW DEPTH SPECIFICATION DURING THE DISPENSER PREPARATION COULD LEAD TO LACK OF SOLVENT. 2. THE EXCESS OF ACTIVITIES PERFORMED BY THE DISPENSER OPERATOR COULD LEAD TO AN INCONSISTENT MANNER OF THE FIXTURE. AS A CORRECTIVE ACTION, TO MITIGATE OR ELIMINATE THE SEPARATION FAILURE MODE BY LACK OF SOLVENT, A PROJECT HAS BEEN FUNDED TO UPDATE SOLVENT APPLICATORS PROCEDURE TO REFLECT OPTIMAL SCREW DEPTH AND PREPARATION. AS A PREVENTATIVE ACTION, MANUFACTURING CELL OPERATIONS PROCEDURE HAS BEEN UPDATED TO MITIGATE THE USE OF THE FIXTURE IN AN INCONSISTENT MANNER BY EXCESS LOADING OF ACTIVITIES. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SEC 20DP, TEXIUM & HANGER V/NV LINE DETACHED BELOW THE DRIP CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE IN USE, LINE DETACHED FROM BELOW THE DRIP CHAMBER."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THE LINE DETACHED FROM BELOW THE DRIP CHAMBER COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 40000-07T BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEC 20DP, TEXIUM & HANGER V/NV LINE DETACHED BELOW THE DRIP CHAMBER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE IN USE, LINE DETACHED FROM BELOW THE DRIP CHAMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167367 SEC 20DP, TEXIUM & HANGER V/NV INTRAVASCULAR ADMINISTRATION SET FPA 40000-07T UNKNOWN 50885403225626

    Patients

    Seq Age Sex Outcome Treatment
    1