BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM

    MDR report key: 12328817 · Received August 16, 2021

    Report

    Report Number
    9616066-2021-51787
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 19, 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: 2021-08-12. H6: INVESTIGATION SUMMARY : SEVEN 8100-027 SAMPLES FROM LOTS 20054055 AND 20034124 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 AND 20034124 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 THAT ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM HAD AIR IN THE LINE ON 34 OCCASIONS AND WAS DAMAGED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT AIR IS ENTERING VALVE DURING ASPIRATION. VERBATIM: DETAILS OF THE COMPLAINT: AIR ENTERING VALVE DURING ASPIRATION. 1 - THE SURFACE OF THE BLUE VALVE STEM IS PITTED AND DEFORMED, WHICH MAY HAVE ALLOWED AIR TO BYPASS THE VALVE DURING USE. 2 - OF THE 30 SAMPLES, ONE ASPIRATED BOTH AIR AND LIQUID THROUGH THE DEVICE. THE TOP OF THE VALVE SHOWED SMALL IMPERFECTIONS ALONG THE OUTER PERIMETER OF THE VALVE AND A ROUGH VALVE SURFACE. THE COLLAR OF THE VALVE SHOWED SMALL OVAL SHAPED DEPRESSIONS IN THE MATERIAL THAT APPEARED TO BE FLOW LINES FOR THE MATERIAL. 3 - A TOTAL OF FOUR SAMPLES WERE RETURNED FOR EVALUATION. WHEN AN ATTEMPT WAS MADE TO ASPIRATE FLUID THROUGH THE DEVICES, ALL FOUR SAMPLES COULD NOT ASPIRATE FLUID BUT INSTEAD ASPIRATED AIR. MICROSCOPIC EXAMINATION OF THE Y-SITE VALVE WAS CONDUCTED. 3 SAMPLES: SAMPLES CONTAINED A SLIGHTLY ROUGH SURFACE TO THE VALVE STEM, SMALL IMPERFECTIONS ALONG THE OUTER PERIMETER OF THE VALVES, AND THE COLLAR OF THE VALVE HAD OVAL SHAPED DEPRESSIONS IN THE MATERIAL. ALL FROM CAVITY 38E. 1 SAMPLE: THE VALVE WAS UNREMARKABLE UNDER MICROSCOPIC OBSERVATION.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20054055. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-05-15. MEDICAL DEVICE LOT #: 20034124. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2020-03-12. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM HAD AIR IN THE LINE ON 34 OCCASIONS AND WAS DAMAGED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT AIR IS ENTERING VALVE DURING ASPIRATION. VERBATIM: DETAILS OF THE COMPLAINT: AIR ENTERING VALVE DURING ASPIRATION. THE SURFACE OF THE BLUE VALVE STEM IS PITTED AND DEFORMED, WHICH MAY HAVE ALLOWED AIR TO BYPASS THE VALVE DURING USE. OF THE 30 SAMPLES, ONE ASPIRATED BOTH AIR AND LIQUID THROUGH THE DEVICE. THE TOP OF THE VALVE SHOWED SMALL IMPERFECTIONS ALONG THE OUTER PERIMETER OF THE VALVE AND A ROUGH VALVE SURFACE. THE COLLAR OF THE VALVE SHOWED SMALL OVAL SHAPED DEPRESSIONS IN THE MATERIAL THAT APPEARED TO BE FLOW LINES FOR THE MATERIAL. A TOTAL OF FOUR SAMPLES WERE RETURNED FOR EVALUATION. WHEN AN ATTEMPT WAS MADE TO ASPIRATE FLUID THROUGH THE DEVICES, ALL FOUR SAMPLES COULD NOT ASPIRATE FLUID BUT INSTEAD ASPIRATED AIR. MICROSCOPIC EXAMINATION OF THE Y-SITE VALVE WAS CONDUCTED. 3 SAMPLES: SAMPLES CONTAINED A SLIGHTLY ROUGH SURFACE TO THE VALVE STEM, SMALL IMPERFECTIONS ALONG THE OUTER PERIMETER OF THE VALVES, AND THE COLLAR OF THE VALVE HAD OVAL SHAPED DEPRESSIONS IN THE MATERIAL. ALL FROM CAVITY 38E. 1 SAMPLE: THE VALVE WAS UNREMARKABLE UNDER MICROSCOPIC OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220888 ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM INTRAVASCULAR ADMINISTRATION SET FPA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1