BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEFANT SUCTION-IRRIGATION DEVICE

    MDR report key: 17267854 · Received July 6, 2023

    Report

    Report Number
    9610711-2023-00134
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 12, 2023
    Report Date
    April 16, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN¿T FIND OTHER COMPLAINT ON THE LOT N° 9141381. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. THE REVIEW OF THE WORK ORDER DIDN'T SHOW ANY ISSUE DURING THE PRODUCTION OF THE LOT N° 9141381. WITHOUT PICTURE AND SAMPLE IT IS HARD TO DETERMINE WHERE THE WELDING FAIL HAPPENED. IN OUR PROCESS WE PUT THE ASP PRODUCTS IN AN INNER POUCH THAT IS OPEN IN ONE END AFTER THAT WE PUT IT INSIDE THE OUTER POUCH AND WE SEAL ONE SIDE OF IT. DUE TO THIS IT IS IMPORTANT TO SEE WHICH WELDING FAILED SO WE CAN KNOW IF WE HAVE A PROBLEM DURING PRODUCTION OR THE RAW MATERIAL.

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE PHARMACEUTICAL ASSISTANT NOTICED THAT THE STERILE PACKAGING PROTECTING A SUCTION CANNULA WAS INCORRECTLY SEALED AND THEREFORE NOT STERILE. THE DEVICE WAS NOT USED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, DURING DISTRIBUTION OF MEDICAL EQUIPMENT FOR THE OPERATING ROOM, THE PHARMACEUTICAL ASSISTANT NOTICED THE STERILE PACKAGING PROTECTING A SUCTION CANNULA WAS INCORRECTLY SEALED AND THEREFORE NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788547 ELEFANT SUCTION-IRRIGATION DEVICE SURGICAL IRRIGATION/ASPIRATION CANNULA, NON-ILLUMINATING, SINGLE-USE FQH COLOPLAST A/S 9141381_ASP1851002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown