BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG

    MDR report key: 7033427 · Received November 15, 2017

    Report

    Report Number
    1226348-2017-10840
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 24, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    K890648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT WE RECEIVED 2 INTEGRATED TUBE/CORD SETS UNITIZED P/N 80-1189, LOT # H78200: 1 WAS IN THE UNOPENED SEALED PACKAGE. IN THE OTHER, THERE IS A HOLE IN THE CONNECTION AREA/SILICONE-PUMPING SEGMENT. THE HOLE WAS FOUND IN THE SILICONE TUBING AND IS ALIGNED WITH END OF THE TOP CONNECTOR. THE ACTUAL DAMAGE IS CONSISTENT WITH THE ABRASION THAT CAN OCCUR WHEN LOADING THE TUBE SET AT EITHER THE UPPER OR BOTTOM SLOTS OF THE IRRIGATION UNIT. DURING LOADING OF THE TUBE SETS, IT IS IMPORTANT TO BE AWARE THAT ABRADING THE SILICONE TUBING AT THE TUBE/CONNECTOR TRANSITION POINT IS POSSIBLE IF THE TUBE SET IS LOADED INTO THE IRRIGATION UNIT IMPROPERLY. WHEN LOADING THE TUBING SET INTO THE IRRIGATION UNIT, THE TUBING SHOULD BE SLIGHTLY STRETCHED SO THAT THE TUBE/CONNECTOR TRANSITION AREA DOES NOT COME IN CONTACT WITH THE SLOT EDGES. ALLOW THEN THE TUBING TO RELAX INTO POSITION INSIDE THE SLOT HOLE, WHICH ACCEPTS THE CONNECTOR. THIS WILL MINIMIZE ANY ABRASION OF THE SILICONE TUBING DURING LOADING. A REVIEW OF THE DHR DID NOT SHOW ANY ANOMALIES DURING THE MANUFACTURING PROCESS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    LEAKAGE WAS NOTED AFTER STARTED THE SURGERY. THE LOCATION OF HOLE IS UNKNOWN. THE PRODUCT WAS REPLACED WITH ANOTHER ONE. THE USED GENERATOR¿S TYPE IS UNKNOWN. USER TRAINING IS SCHEDULED TO BE DONE. THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THE PRODUCT WILL BE RETURNED TO YOUR SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812291 CODMAN MALIS INTEGRATED TUBE SET UNITIZED PLUG IRRIGATION TUBING SET, GENERAL PURPOSE GEI CODMAN & SHURTLEFF, INC. H78200

    Patients

    Seq Age Sex Outcome Treatment
    1