BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS

    MDR report key: 8623261 · Received May 20, 2019

    Report

    Report Number
    1317056-2019-00066
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Report Date
    August 13, 2019
    Manufacturer
    ANGIODYNAMICS
    Product Code
    OEZ
    UDI-DI
    H965601910111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE JUNE 2019 FLUID MANAGEMENT COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE "DEVICE - AIR BUBBLES. " NO ADVERSE TREND WAS INDICATED. THIRTEEN UNOPENED CONVENIENCE KITS WERE RETURNED FROM THE END USER HOSPITAL NO USED SAMPLES WERE RETURNED. THE FOLLOWING INSPECTION ACTIVITIES WERE PERFORMED ON ALL 13 SAMPLES RETURNED: VISUAL/MICROSCOPIC EXAM: AS RECEIVED, THE PRESSURE MONITORING LINE (PML) AND BONDED COMPONENT ITEM NUMBERS {40701722 AND 40400052} WERE UNOPENED. A VISUAL INSPECTION OF THE FEMALE AND MALE LUER LOCK OF THE PML AND BONDED COMPONENT FEMALE LUER USING A MICROSCOPE SHOWED NO VISUAL DEFECTS. FUNCTIONAL CHECK: BONDED DEVICE: THE MALE TAPER WAS VERIFIED TO BE WITHIN SPECIFICATION PER MANUFACTURING PROCEDURES, USING ISO TAPER GAUGE. DIMENSIONAL CHECK: THE FEMALE TAPER WAS VERIFIED TO MEET SPECIFICATION PER MANUFACTURING PROCEDURES, USING THE ISO FEMALE TAPER GAUGE. THE FEMALE THREADS WERE MEASURED USING CALIPERS AND FOUND TO BE WITHIN SPECIFICATION. PML: THE MALE TAPER OF THE PML WAS VERIFIED TO BE WITHIN SPECIFICATION PER MANUFACTURING PROCEDURES, USING ISO TAPER GAUGE. BONDED COMPONENT AND PML THE BONDED DEVICE AND PML WAS LEAK TESTED AT 12 PSI OF AIR USING A HEISE.THE SAMPLE PASSED THE LEAK TEST REQUIREMENTS PER MANUFACTURING PROCEDURES. THE PML CONNECTED AND DISCONNECTED TO THE BONDED COMPONENT THREE TIMES. NO CONNECTION ISSUES WERE OBSERVED. THE END USER'S COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. THERE WERE NO MANUFACTURING RELATED DEFECTS NOTED IN THE RETURNED SAMPLE. THE SAMPLES WERE EVALUATED AND WAS FOUND VISUALLY, DIMENSIONAL AND FUNCTIONALLY ACCEPTABLE. BASED ON THE SAMPLE EVALUATION THE END USER'S COMPLAINT DOES NOT APPEAR TO BE A MANUFACTURING RELATED ISSUE. POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE PML AND THE BONDED COMPONENT OR THE DEVICE THEY WERE CONNECTING TO WERE NOT "FINGER TIGHTENED" PRIOR TO USE AS IT IS STATED IN THE DIRECTIONS FOR USE (DFU) PROVIDED TO THE END USER IN THE REPORTED KIT. THE DFU CONTAINS THE FOLLOWING STATEMENTS, "ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR THAT COULD RESULT IN EMBOLISM AND OR EXPOSURE TO BIOHAZARDS." (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN INDICATED THAT USED AND UNUSED DEVICE SAMPLES WILL BE RETURNED FOR EVALUATION, HOWEVER THEY HAVE NOT YET ARRIVED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. ((B)(4)).

    Description of Event or Problem · 1

    AS REPORTED, WITH A CONVENIENCE KIT, AIR BUBBLES WERE BELIEVED TO BE ENTERING THE LINE AT THE CONNECTION OF THE DISPOSABLE TRANSDUCER AND THE PRESSURE MONITORING LINE. "THE CONNECTIONS WERE THEN TIGHTENED, AND EVENTUALLY CHANGED OUT." NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. SAMPLES ARE BEING RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417877 ANGIODYNAMICS CARDIOVASCULAR PROCEUDRE KIT OEZ ANGIODYNAMICS 5450161 H965601910111

    Patients

    Seq Age Sex Outcome Treatment
    1