BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10232865 · Received July 6, 2020

    Report

    Report Number
    9616066-2020-02066
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 16, 2020
    Report Date
    June 16, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A 2000E CHINA SAMPLE WAS NOT REQUIRED FOR INVESTIGATION OF THIS FEEDBACK AS THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF THE PHOTOGRAPH CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE FEMALE LUER ADAPTOR OF THE SMARTSITE NOTED TO HAVE A YELLOWED APPEARANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19075428 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE THAT YELLOW DISCOLORATION OF COMPONENTS CAN TYPICALLY OCCUR AFTER IRRADIATION STERILIZATION AND THE DEGREE OF DISCOLORATION CAN CHANGE OVER TIME AND UNDER CERTAIN STORAGE CONDITIONS. THIS TYPE OF DISCOLORATION DOES NOT AFFECT THE FUNCTIONALITY OF THE DEVICE AND THEREFORE IS NOT CONSIDERED TO BE A DEFECT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT REPORTS OF THIS NATURE AGAINST PRODUCTS MANUFACTURED AT THIS MANUFACTURING SITE OCCUR AT A LOW FREQUENCY AND HAVE NOT BEEN ATTRIBUTABLE TO A PRODUCT DEFECT OR MANUFACTURING ISSUE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE REMOVING IT FROM THE PACKAGING, THE LL VLV ADPT(STAND ALONE) WAS FOUND TO BE DISCOLORED TO "YELLOW AND KHAKI". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE COLOR OF THE CONNECTOR WAS YELLOW AND KHAKI, WHICH WAS VERY OBVIOUS. A BOX OF 50 FOUND THIS ONE EXAMPLE, AND THIS BOX REFUSED TO USE."

    Additional Manufacturer Narrative · 1

    2000E CHINA 510K: THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT - K960280. INVESTIGATION SUMMARY: A 2000E CHINA SAMPLE WAS NOT REQUIRED FOR INVESTIGATION OF THIS FEEDBACK AS THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLES; ANALYSIS OF THE PHOTO CONFIRMED THE CUSTOMER'S EXPERIENCE WITH DISCOLOURATION OF THE FEMALE LUER COMPONENT. ROOT CAUSE ANALYSIS: DHR. HERE¿S THE DHR FOR THE INVOLVED LOT NUMBER: PR: (B)(6), LOT: 19075428, MODEL: 2000E CHINA, QTY: (B)(4), QN/DEVIATION: NONE, MFG DATE: 7-MAY-19. STERILIZATION: INTERNAL RECORDS FOR LOT RELEASE IN SAP SHOW THAT THE LOT MET ALL STERILIZATION PROCESSING CRITERIA AND NO DEVIATIONS WERE NOTED AND PRODUCT SUCCESSFULLY RELEASED TO CUSTOMER. THIS PRODUCT IS VALIDATED FOR GAMMA STERILIZATION. IF THERE ARE NO FOUND ISSUES AT THE MANUFACTURING LEVEL, IT CAN BE CONCLUDED THAT THE SLIGHT DISCOLORATION AS DEPICTED IS A TYPICAL RESULT OF THE RADIATION PROCESS KNOWN TO DEGRADE POLYMERS. AGAIN, ALSO BASED ON THE AGE OF THE SET AND TAKING INTO ACCOUNT VARIOUS (CUSTOMER) STORAGE CONDITIONS NOT IN OUR CONTROL, THE PLASTICS ARE DEGRADING AND ¿YELLOWING/BROWNING¿ IS A RESULT. IF THERE ARE NO OTHER ISSUES FOUND WITH THE SET IN OTHER INVESTIGATIVE AREAS, THE SAFETY, STERILITY AND FUNCTIONALITY SHOULD NOT BE IMPACTED BY THE OBSERVED DISCOLORATION. INVESTIGATION CONCLUSION: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19075428 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE THAT YELLOW DISCOLOURATION OF COMPONENTS CAN TYPICALLY OCCUR AFTER IRRADIATION STERILISATION AND THE DEGREE OF DISCOLOURATION CAN CHANGE OVER TIME AND UNDER CERTAIN STORAGE CONDITIONS. THIS TYPE OF DISCOLOURATION DOES NOT AFFECT THE FUNCTIONALITY OF THE DEVICE AND THEREFORE IS NOT CONSIDERED TO BE A DEFECT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT REPORTS OF THIS NATURE AGAINST PRODUCTS MANUFACTURED AT THIS MANUFACTURING SITE OCCUR AT A LOW FREQUENCY AND HAVE NOT BEEN ATTRIBUTABLE TO A PRODUCT DEFECT OR MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE REMOVING IT FROM THE PACKAGING, THE LL VLV ADPT(STAND ALONE) WAS FOUND TO BE DISCOLORED TO "YELLOW AND KHAKI". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE COLOR OF THE CONNECTOR WAS YELLOW AND KHAKI, WHICH WAS VERY OBVIOUS. A BOX OF 50 FOUND THIS ONE EXAMPLE, AND THIS BOX REFUSED TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697722 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA CFN MEXICO 215 SA DE CV 2000E CHINA 19075428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200616| 20200616