BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE TAMPONADE ACCESSORIES

    MDR report key: 18128588 · Received November 14, 2023

    Report

    Report Number
    1222074-2023-00082
    Event Type
    Malfunction
    Date Received
    November 14, 2023
    Date of Event
    October 20, 2023
    Report Date
    September 1, 2024
    Manufacturer
    D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS UNDER INVESTIGATION. IN CASE OF A PRODUCT RETURN, THE DEVICE WILL BE INVESTIGATED, OTHERWISE WE WILL REVIEW THE DEVICE HISTORY RECORD, AND/OR ANY LOG FILES IF AVAILABLE, OR TRY TO REPLICATE THE PROBLEM ON SIMILAR PRODUCT. AS INVESTIGATIONS ON THE ACTUAL PRODUCT OR REPRESENTATIVE SAMPLE OF A BATCH MAY ALTER THE DEVICE, WE REQUEST TO INFORM US WITHIN 7 DAYS AFTER SUBMISSION OF THIS REPORT, IN CASE THE INVESTIGATIONS THAT ALTER THE DEVICE SHOULD BE HALTED UNTIL APPROVAL OF THE NCA, AS PER ARTICLE 89 OF EU-MDR.

    Additional Manufacturer Narrative · 0

    SINCE THE INVOLVED VFI TUBE WAS NOT RETURNED TO DORC, NO PHYSICAL EXAMINATION COULD BE PERFORMED TO CONFIRM THE REPORTED FAILURE. DEVICE HISTORY RECORD REVIEW REVEALED NO DEVIATIONS AND A DATABASE SEARCH SHOWED THAT NO SIMILAR COMPLAINTS HAVE BEEN REPORTED ON THIS SPECIFIC LOT PREVIOUSLY. THE RISK IDENTIFIED IS INCLUDED IN THE RISK MANAGEMENT DOCUMENTATION. TREND ANALYSIS INDICATES THAT THE PRODUCT IS PERFORMING WITHIN ANTICIPATED RATES. COMPLAINTS WILL BE CLOSELY MONITORED TO IDENTIFY ANY SIGNIFICANT ADVERSE TRENDS.THOUGH THE FAILURE COULD NOT BE CONFIRMED FOR THIS PARTICULAR CASE, DORC IS AWARE THAT, ON RARE OCCASIONS, THE BOND BETWEEN THE PVC TUBING AND SILICONE TUBING MAY FAIL DURING SILICONE OIL INJECTION. THOUGH THIS TYPE OF FAILURE SEEMS TO OCCUR MOSTLY WHEN A HIGH PRESSURE (> 5 BAR) IS APPLIED, AN INVESTIGATION HAS RECENTLY BEEN INITIATED TO DETERMINE THE CAUSE OF THIS FAILURE AND TO EXPLORE OPPORTUNITIES FOR PRODUCT IMPROVEMENT (DTP 2023-475) THE ANALYSIS INCLUDES ALL COMPLAINTS WITH FAILURE MODE VFI-TUBING-SPLIT(-XX) AND THE DISTRIBUTION FIGURES OF THE 1279.VFI TUBE SET (IN PCS).

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE, THE INFUSION LINE SEPARATED INTO TWO PIECES LEADING THE PRACTITIONER TO CHANGE THE INFUSION LINE DURING THE PROCEDURE. NO REPORT THAT ACTUAL PATIENT HARM HAS OCCURRED OR SURGERY WAS PROLONGED 30 MINUTES.

    Description of Event or Problem · 0

    WE HAVE BEEN INFORMED THAT DURING PROCEDURE, THE INFUSION LINE SEPARATED INTO TWO PIECES LEADING THE PRACTITIONER TO CHANGE THE INFUSION LINE DURING THE PROCEDURE. NO REPORT THAT ACTUAL PATIENT HARM HAS OCCURRED OR SURGERY WAS PROLONGED > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203386 DISPOSABLE TAMPONADE ACCESSORIES UNIVERSAL PVC INFUSION LINE FOR 23G CANNULA SYSTEM FOR VFI/VFE HQC D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. 332-*-*-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown