BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM

    MDR report key: 10318254 · Received July 23, 2020

    Report

    Report Number
    9616066-2020-02233
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 6, 2020
    Report Date
    July 5, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B4: DATE EVENT REPORTED TO CFN: 07/05/2020. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 07/28/2020. E1: INITIAL REPORTER: (B)(6). INVESTIGATION CONCLUSION: A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED: BD PRODUCT MODEL: 8100-027. REPORTED LOT NUMBER: 20054047. NO QN¿S DURING THIS LOT MANUFACTURING. 9 SAMPLES OF THE 8100-027 WAS RECEIVED AND IT WAS VISUALLY INSPECTED. DURING VISUAL INSPECTION, THE FAILURE MODE WAS CONFIRMED TO BE IN THE BOTTOM SIDE OF THE BODY, DURING THE VISUAL INSPECTION, IT WAS DISREGARDED ANY POSSIBILITY OF DAMAGE AND IT WAS OBSERVED TO BE RELATED TO THE MOLDING TEAM. A PROCESS REVISION WAS CONDUCTED BY THE MOLDING TEAM, THE REPORTED MODEL LOT WAS REVIEWED IN COMPONENT LEVEL (TC10009225), A QN REVISION WAS CONDUCTED AND IT WAS FOUND ONE (B)(4) RELATED TO A SHORT SHOT IN THE BOTTOM OF THE BODY, IT CONFIRMED THAT THE REPORTED FAILURE MODE WAS KNOWN IN PRODUCTION AND IS RELATED TO A MECHANICAL ISSUE IN THE MOLDING MACHINE PE-1107-0032; HOWEVER, A 100% INSPECTION IS PERFORMED UNDER THE INTERNAL PROCEDURE GID0084.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM HAD CREVICES. THIS WAS DISCOVERED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 8100-027 BATCH #: 20054047. IT WAS REPORTED THERE ARE CREVICES ON THE TOP OF Y SITES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 CREVICES. THIS WAS DISCOVERED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: 8100-027 BATCH #: 20054047. IT WAS REPORTED THERE ARE CREVICES ON THE TOP OF Y SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776615 ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION 8100-027 20054047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other