BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 12140443 · Received July 8, 2021

    Report

    Report Number
    2648988-2021-00009
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 14, 2021
    Report Date
    February 25, 2022
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCUDRAIN EVD SYSTEM (INS8401) WITH LOT #459086 WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) ¿ THE DHR WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT INCIDENT WAS OBSERVED. FAILURE ANALYSIS -THE CUSTOMER REPORTED THAT THE FG LOT # 5170818 WAS INVOLVED IN THE INCIDENT, BUT THE PANEL LABEL ON THE RETURNED DEVICE SHOWS THE FG LOT # 4759086. THE COMPLAINT SYSTEM WAS REVIEWED BUT NO COMPLAINT HAS BEEN RELATED TO THE FG LOT 4759086. ALTHOUGH THE RETURNED DEVICE IS NOT THE REPORTED ONE, IT WAS EVALUATED. THE EVALUATION WAS FOCUSED TO THE STOPCOCK WHERE THE DRAINAGE BAG IS CONNECTED ACCORDING TO THE COMPLAINT DESCRIPTION. THE DRAINAGE BAG WAS OBSERVED DISCONNECTED FROM THE STOPCOCK MALE LUER LOCK. THE VISUAL EVALUATION DID NOT IDENTIFY ANY CRACK OR ANOMALY ON THE STOPCOCK OR DRAINAGE BAG CONNECTIONS. THE DRAINAGE BAG WAS CONNECTED TO THE STOPCOCK AND WHOLE SYSTEM WAS TESTED USING WATER FOR ANY LEAKAGE CONDITION. NO LEAKAGE CONDITION OR DRAINAGE DISCONNECTION WAS OBSERVED. THE SYSTEM DID NOT SHOW ANY MALFUNCTION IN THE REPORTED COMPONENTS AND THEREFORE IT IS CONSIDERED UNCONFIRMED. ROOT CAUSE -THE RETURNED DEVICE WAS VISUALLY EVALUATED IN THE STOPCOCK AND THE DRAINAGE BAG CONNECTIONS, BUT THEY WERE FOUND IN ACCEPTABLE CONDITIONS (I.E., NO CRACKS). IN ADDITION, WATER WAS INTRODUCED THROUGH THE WHOLE SYSTEM FOR ANY LEAKAGE CONDITION AND NO ANOMALY WAS OBSERVED. THEREFORE, THE REPORTED CONDITION COULD NOT BE CONFIRMED SINCE THE RETURNED UNIT WAS IN GOOD CONDITION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED CONDITION. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS WERE IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Additional Manufacturer Narrative · 0

    ACCUDRAIN WITH ANTI-REFLUX VALVE (INS8401) WAS NOT RETURNED FOR EVALUATION. THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED. THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. HOWEVER, ACCORDING TO THE ADDITIONAL DATA PROVIDED IN WHICH THE CUSTOMER INFORMED THAT THE DEVICE WAS CONNECTED TO THE PATIENT, AND THE BAG CONNECTOR BROKE DURING A BAG EXCHANGE CAUSING A BREACH TO THE DRAINAGE PATHWAY. IT CAN BE CONCLUDED THAT PREVIOUSLY THE DEVICE WAS IN GOOD CONDITION AND PERFORMING AS EXPECTED ACCORDING TO THE INTEGRA¿S SPECIFICATIONS AND INSTRUCTIONS FOR USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT BASED ON THE FOREGOING IS THAT THE BAG CONNECTOR BROKE DURING HANDLING OF THE PRODUCT WHILE THE BAG WAS BEING EXCHANGED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE ACCUDRAIN WITH ANTI-REFLUX VALVE (INS8401) BAG CONNECTOR BROKE DURING BAG EXCHANGE. THE DEVICE WAS CONNECTED TO A PATIENT AND WAS USED FOR CEREBROSPINAL FLUID (CSF) COLLECTION. THERE WAS NO PATIENT INJURY AND NO DELAY IN THE PROCEDURE. HOWEVER, DUE TO THE PROBLEM, AN ADDITIONAL PROCEDURE WAS REQUIRED BY THE NEUROSURGERY TEAM AS THE CRACKING AT THE BAG CONNECTION SITE CAUSED THE SYSTEM TO NO LONGER BE STERILE, SO THEY REPLACED THE ENTIRE SYSTEM. THIS INCREASED THE PATIENT¿S RISK FOR INFECTION DUE TO HAVING TO OPEN THE STERILE CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036563 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 4759086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown