BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY NAC-Y SITE (0.088 TUBING)

    MDR report key: 12471097 · Received September 14, 2021

    Report

    Report Number
    9616066-2021-52050
    Event Type
    Malfunction
    Date Received
    September 14, 2021
    Date of Event
    August 17, 2021
    Report Date
    September 28, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-22. H6: INVESTIGATION SUMMARY : TWO 8100-027 SAMPLES FROM LOT 20054055 WERE RECEIVED BY THE MANUFACTURING SITE FOR INVESTIGATION. THEIR ANALYSIS CONFIRMED THE CUSTOMER'S EXPERIENCE AS SMALL OVAL DEPRESSIONS WERE IDENTIFIED IN THE VALVE PISTON OF THE RETURNED SAMPLES. IT WAS ALSO NOTED THAT THE 8100-027 SAMPLES WERE RECEIVED BROKEN INTO THREE PIECES; THE VALVE BODY, THREADED CAP, AND BLUE PISTON WERE ALL RECEIVED SEPARATED. THE CUSTOMER ALSO PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH IDENTIFIED THE A SMALL GAP BETWEEN THE WHITE VALVE BODY AND THE BLUE PISTON WHICH COULD HAVE CONTRIBUTED TO THE REPORTED AIR IN LINE. THE INVESTIGATION CONDUCTED BY THE MANUFACTURING SITE CONFIRMED THAT THE OBSERVED ISSUE IS LIKELY TO HAVE OCCURRED DURING THE MOLDING PROCESS WHERE THE MOLDING CAVITY DID NOT FILL SUFFICIENTLY AND RESULTED IN THE COMPONENT NOT BEING CORRECTLY FORMED. A DEFINITIVE ROOT CAUSE FOR THE SHORT SHOT COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE FOR SUCH A DEFECT TO BE GENERATED AS A RESULT OF AN IMPROPER START-UP OF THE MOLDING MACHINE; OR DUE TO A DAMAGED GATE PIN, WHICH WOULD CAUSE MATERIAL TO LEAK PAST THE NOZZLE TIP, RESULTING IN CURED MATERIAL INTERRUPTING THE FLOW OF SILICONE INTO THE MOLD. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20054055 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. SINCE THE MANUFACTURE OF THE REPORTED LOT, THE SUPPLIER OF THE PISTON HAS REPLACED THE VALVE GATE PINS OF THE AFFECTED MOLD, WHICH SHOULD ENSURE THAT REPORTS OF THIS NATURE ARE REDUCED IN FUTURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH THIS CUSTOMER BEING THE ONLY CUSTOMER TO PROVIDE THIS TYPE OF FEEDBACK AGAINST THE 8100-027 IN THE PAST 12 MONTHS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO ASSEMBLY NAC-Y SITE (0.088 TUBING) HAD AIR BUBBLES/AIR IN LINE/GENERAL DISSATISFACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN AN ATTEMPT WAS MADE TO ASPIRATE FLUID, BOTH AIR AND FLUID WERE ASPIRATED. THE COLLAR OF THE VALVE (SEALING SURFACE) SHOWED SMALL OVAL SHAPED DEPRESSIONS IN THE MATERIAL THAT APPEARED TO BE FLOW LINES FOR THE MATERIAL".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: THERE IS NO EXPIRATION FOR THIS MATERIAL NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO ASSEMBLY NAC-Y SITE (0.088 TUBING) HAD AIR BUBBLES/AIR IN LINE/GENERAL DISSATISFACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN AN ATTEMPT WAS MADE TO ASPIRATE FLUID, BOTH AIR AND FLUID WERE ASPIRATED. THE COLLAR OF THE VALVE (SEALING SURFACE) SHOWED SMALL OVAL SHAPED DEPRESSIONS IN THE MATERIAL THAT APPEARED TO BE FLOW LINES FOR THE MATERIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365251 ASSEMBLY NAC-Y SITE (0.088 TUBING) INTRAVASCULAR ADMINISTRATION SET FPA 20054055

    Patients

    Seq Age Sex Outcome Treatment
    1