BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YELLOPORT PLUS

    MDR report key: 13265034 · Received January 17, 2022

    Report

    Report Number
    9680952-2022-00001
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    January 13, 2022
    Report Date
    February 2, 2022
    Manufacturer
    SURGICAL INNOVATIONS LTD
    Product Code
    GCJ
    UDI-DI
    05051986001890
    PMA / PMN Number
    K070712
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    URGENT FIELD SAFETY NOTICE REVISED ON 20TH JANUARY TO ADD AN ADDITIONAL PART NUMBER/LOT NUMBER. PART NUMBER:: EA10NH. DESCRIPTION: HASSON ADAPTOR 10MM. LOT NUMBER: 734029.

    Additional Manufacturer Narrative · 0

    URGENT FIELD SAFETY NOTICE REVISED ON 20TH JANUARY TO ADD AN ADDITIONAL PART NUMBER/LOT NUMBER. PART NUMBER:: EA10NH. DESCRIPTION: HASSON ADAPTOR 10MM. LOT NUMBER: 734029. CORRECTED TO REMOVE "5 DAY", FIRST REPORT TYPE SHOULD HAVE BEEN 'INITIAL' WHEN FIRST REPORTED ON 17TH JANUARY 2022, AND CHANGED TO FOLLOW UP REPORT 2.

    Additional Manufacturer Narrative · 0

    URGENT FIELD SAFETY NOTICE REVISED ON 20TH JANUARY TO ADD AN ADDITIONAL PART NUMBER/LOT NUMBER. PART NUMBER:: EA10NH; DESCRIPTION: HASSON ADAPTOR 10MM; LOT NUMBER: 734029. REVISED URGENT FIELD SAFETY NOTICE IS ATTACHED TO THIS REPORT. G6 REPORTING CORRECTED TO REMOVE "5 DAY", FIRST REPORT TYPE SHOULD HAVE BEEN 'INITIAL' WHEN FIRST REPORTED ON 17TH JANUARY2022, AND CHANGED TO FOLLOW UP REPORT 2. INVESTIGATION REPORT ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.

    Description of Event or Problem · 0

    AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.

    Description of Event or Problem · 0

    AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.

    Description of Event or Problem · 0

    AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.

    Description of Event or Problem · 0

    AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080234 YELLOPORT PLUS YELLOPORT PLUS 5X70 CANNULA + LUER GCJ SURGICAL INNOVATIONS LTD YC0507001 735652 05051986001890

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown