BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 5974631 · Received September 23, 2016

    Report

    Report Number
    2648988-2016-00041
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 8, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 05 OCT 2016. VISUAL EVALUATION OF PICTURES OF DEVICE. DHR REVIEW. REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION, BUT PICTURES OF THE DEVICE WERE PROVIDED; THUS, CONFIRMING THE FAILURE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN PERFORMED OF LOT NUMBER 1160530 WAS REVIEWED. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED ON APRIL 22, 2016. STOPCOCK LOT USED FOR THIS LOT WAS 3152752 (P/N 200407-001). AS PART OF STOPCOCK INCOMING RELEASE, THE LOT IS VERIFIED 100% FOR CRACKS AND STRESS MARKS UNDER A MICROSCOPE 3X AS PER TM-1059 (VISUAL INSPECTION OF 4-WAY STOPCOCK). AFTER THE 100% INSPECTION, QA SAMPLES AND INSPECTS (B)(4) UNITS AS PER TM-1059. INCOMING RECORDS FOR THE STOPCOCK WERE REVIEWED AND THEY WERE FOUND TO MEET CURRENT REQUIREMENTS. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM SEPTEMBER 2014 TO SEPTEMBER 2016, THERE ARE TWO (2) OTHER COMPLAINTS RELATED TO ¿BROKEN/CRACKED STOPCOCK¿. THIS LOT NUMBER (1160530) HAS NOT BEEN REPORTED IN ANY OTHER COMPLAINT. APPROXIMATELY (B)(4) UNITS OF ACCUDRAIN¿S EXTERNAL DRAINAGE PRODUCT FAMILIES AND ACCESSORIES WERE RELEASED FOR DISTRIBUTION FROM SEPTEMBER 2014 TO SEPTEMBER 2016. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN (B)(4). THIS WAS DETERMINED BY DIVIDING THE NUMBER OF COMPLAINTS IN THIS CATEGORY (B)(4) BY THE NUMBER OF UNITS RELEASED FOR DISTRIBUTION PURPOSES (B)(4) TIMES 100. CONCLUSION: FROM THE PICTURE PROVIDED, THE BROKEN STOPCOCK APPEARS TO BE THE ONE LOCATED AT THE PATIENT¿S LINE. PATIENT LINE IS 100% LEAK TESTED DURING THE MANUFACTURING ASSEMBLY PROCESS. WHEN ASSEMBLED, THE DEVICE HAS A YELLOW CAP ON THE BROKEN PART OF THE STOPCOCK; THUS, THIS AREA IS ALSO TESTED DURING LEAK TEST. IF THE STOPCOCK WAS CRACKED OR BROKEN, IT WOULD HAVE BEEN REJECTED DURING THE LEAK TEST PERFORMED. THE WAY THIS STOPCOCK IS BROKEN IT WOULD BE DIFFICULT TO MISS DURING ASSEMBLY AND INSPECTION OF THE DEVICE DURING MANUFACTURING/PACKAGING OPERATIONS OR EVEN DURING DEVICE SETUP AT THE USER END. THE MOST PROBABLE CAUSE FOR THE BREAKAGE APPEARS TO BE DUE TO THE USE OF EXCESSIVE FORCE OR TO AN UNINTENDED BLOW/ HIT DURING PRODUCT HANDLING,

    Description of Event or Problem · 1

    THE DEVICE BROKE NEAR THE LUER LOCK. THE PRODUCT WAS IN CONTACT WITH PATIENT BUT THERE WAS NO PATIENT INJURY OR DEATH ALLEGED. THE EVENT DID LEAD TO AN INCREASE OF SURGERY TIME OF 15 MINUTES. THE REASON FOR USE OF THE ACCUDRAIN WAS FOR DRAINAGE OF CEREBROSPINAL FLUID. THE LUER BROKE DURING THE REMOVAL OF CEREBROSPINAL FLUID. THE REASON FOR THE 15 MINUTE DELAY WAS BECAUSE THE SYSTEM HAD TO BE REPLACED BY A NEW SYSTEM. THERE WAS NO PATIENT ADVERSE CONSEQUENCE DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625922 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1