BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISITE ARTERIAL CANNULA

    MDR report key: 19580714 · Received June 21, 2024

    Report

    Report Number
    2015691-2024-04781
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 22, 2024
    Report Date
    July 30, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQR
    PMA / PMN Number
    K073559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION B4: (DATE OF THIS REPORT) AND G3: (DATE RECEIVED BY MANUFACTURER). H11: ADDITIONAL MANUFACTURER NARRATIVE: THIS IS ONE OF THE TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THE SAME EVENT. REFERENCE RELATED MANUFACTURER REPORT NUMBER: 2015691 2024 04782. CORRECTED DATA: THE ISSUE IS RELATED TO A WRONG LABELING FOR CANNULA WITH A POTENTIAL RISK FOR THE SURGEON TO USE A WRONG SIZE. HOWEVER, THE USERS ARE HIGHLY TRAINED SURGEONS, THE POUCH AND PRODUCTS HAVE THE SIZE CLEARLY IDENTIFIED AND IN THE CASE THE SURGEON WOULD STILL USE THE WRONG SIZE CANNULA, HE/SHE WOULD IMMEDIATELY NOTICE THIS WHEN TRYING TO INSERT THE CANNULA AND WILL USE ANOTHER DEVICE. THEREFORE, THIS LABELING ISSUE WILL RESULT ONLY IN PROCEDURAL DELAY WITH NO RISK FOR THE PATIENT. BASED ON THIS INFORMATION, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: PRODUCT WAS NOT RETURNED FOR EVALUATION BECAUSE IN THIS CASE, IMAGES PROVIDED ARE SUFFICIENT FOR THE PRODUCT INVESTIGATION. PICTURES OF THE AFFECTED SAMPLES WERE REVIEWED. CUSTOMER REPORT OF INCORRECTLY PACKAGED WAS CONFIRMED. FIRST IMAGE SHOWED SEVEN SHELF BOXES LABELLED MODEL OPTI18 AND LOT NUMBER 13175. SECOND IMAGE SHOWED SEVEN TYVEK POUCH COVERS LABELLED MODEL OPTI22 AND LOT NUMBER 132200 AND THE COUNTRY SPECIFIC LABELLED MODEL OPTI18. THIRD IMAGE SHOWED A CANNULA LABELLED OPTI22. FOURTH IMAGE SHOWED ONE LABEL WITH OPTI22 AND LOT 132200 AND COUNTRY SPECIFIC LABEL WITH OPTI18. FIFTH IMAGE SHOWED A LABEL WITH OPTI18 AND LOT 132175. SIXTH IMAGE SHOWED SEVEN SHELF BOXES. LABELS WERE NOT LEGIBLE FROM THE PROVIDED PHOTO. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT DISCREPANCIES ON LABELING INFORMATION WERE OBSERVED IN SEVEN (7) OPTI22 CANNULAS LOT NO 132200. AS REPORTED, SOURCE LABELING ATTACHED TO INNER PACKAGE LAYER (POUCH) SHOWED OPTI22 CANNULAS LOT NO 132200. HOWEVER, OUTER BOX LABELING AND SUPPLEMENTAL LABELING ATTACHED TO THE INNER PACKAGE LAYER (POUCH) WERE SHOWING OPTI18 LOT NO. 132175. REPORTEDLY, THE ISSUE WAS FIRSTLY DETECTED IN ONE OF THE SEVEN CANNULAS THAT WAS SENT TO THE END CUSTOMER, WHO ENCOUNTER THE LABELING DISCREPANCY BEFORE ENTERING THE OPERATING ROOM (CURRENT MEDWATCH # 49660). THE DEVICE WAS NOT USED. CONSEQUENTLY, THE DISTRIBUTOR CHECKED THE OTHER SIX (6) UNITS OF THE SAME LOT THAT WERE STILL ON THE DISTRIBUTOR WARD AND THEY FOUND THE SAME ISSUE (MEDWATCH # 49661). ALL SEVEN (7) AFFECTED UNITS WERE PUT IN QUARANTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182662 OPTISITE ARTERIAL CANNULA CANNULA, CATHETER DQR EDWARDS LIFESCIENCES OPTI18

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown