BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 6042353 · Received October 19, 2016

    Report

    Report Number
    9610825-2016-00653
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    September 23, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    PMA / PMN Number
    K021094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLES WERE RECEIVED FOR FURTHER EVALUATION. MULTIPLE ATTEMPTS TO OBTAIN SAMPLES, WERE NOT SUCCESSFUL. PROCESS CARDS SHOW NO ABNORMALITIES. TREND ANALYSIS COMPLAINT TRENDING FROM YEAR 2014 TO AUG 2016 FOR SIMILAR DEFECT OF FAILURE CLIP FUNCTION OF INTROCAN WERE ANALYSED. COMPLAINT OCCURRENCE FOR JUSTIFIED AND NOT JUDGEABLE COMPLAINT CASE WAS CALCULATED AS BELOW. THE COMPLAINT ANALYSIS SHOWED DECREASING TREND FROM YEAR 2014 TO 2016 FROM 0.24 PPM TO 0.11 PPM. ALL THE JUSTIFIED CASES WERE INVESTIGATED TO THE EXTENT POSSIBLE BASED ON AVAILABILITY OF INFORMATION PROVIDED. NO JUSTIFIED COMPLAINT WERE REPORTED AFTER CA IMPLEMENTED. REVIEW ON PRODUCTION PROCESS FLOW AS BELOW, CAM & ECM MACHINE HAS ONLINE VISION SYSTEM TO CONDUCT 100% CHECKING ON RELEVANT CRITICAL DIMENSION OF CANNULA INCLUDING CRIMP WIDTH, CRIMP LENGTH, CLIP DIMENSION AND CLIP POSITION. ALL THE DEFECTIVE PARTS WILL BE AUTOMATICALLY REJECTED BY MACHINE. THE IN-LINE TEST EQUIPMENT IS SUBJECT OF A FREQUENT CALIBRATION AND A REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN-TIME AND WOULD BE MITIGATED ASAP. BESIDE THE AUTOMATED 100% IN-LINE TEST EQUIPMENT INDEPENDENT IN-PROCESS QUALITY CONTROLS AND FINAL CONTROLS ON A RANDOM SAMPLE BASIS WILL BE CONDUCTED BY DIFFERENT TEAMS ON A REGULAR BASIS WITHIN THE PRODUCTION PROCESS. HEREWITH A SYSTEMATIC PRODUCT DEFECT WOULD BE DETECTED. FINAL CONTROL RESULT FOR COMPLAINT BATCH: CLIP FUNCTION TEST. CLIP FUNCTION SPECIFICATION: THE NEEDLE CLIP MUST BE BLOCKED AND THE NEEDLE TIP MUST NOT PUNCTURE THROUGH THE GLOVE. THE COMPLAINT BATCH PASSED CLIP FUNCTION TEST AND SHOWED NO ABNORMALITIES. FOR CLIP FAIL TO ENGAGE, THE DEFECTS HAS BEEN THOROUGHLY INVESTIGATED AND A CORRECTIVE ACTION HAS BEEN TAKEN ACCORDINGLY. THE REPORTED COMPLAINT BATCH WAS MANUFACTURED BEFORE THE CA IMPLEMENTED. HENCE, SIMILAR CORRECTIVE ACTION IS APPLICABLE FOR THIS DEFECT. DHR HISTORY RECORD REVIEW SHOWED NO DEVIATION AT IN-PROCESS AND FINAL CONTROL INSPECTION AND THE COMPLAINT BATCH PASS CLIP FUNCTION TEST. THE ACTUAL SAMPLE INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR EVALUATION. CAUSE COULD NOT BE DETERMINED. THE COMPLAINT IS ONLY TAKEN TO THE KNOWLEDGE AND FILED FOR STATISTICAL PURPOSE. HOWEVER, IF THE SAMPLE AND/OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT 2: "THE CATHETERS WERE JAMMING AND NOT DRAWING BACK AND LOCKING FOR SAFETY." PER CUSTOMER'S FEEDBACK, "I HAD 2 LOT NUMBERS IN STOCK AT THE SAME TIME. I'M NOT SURE IF THE PROBLEMS OCCURRED WITH BOTH LOTS. THESE WERE THE INTROCAN SAFETY 18G ANGIOS WITH THE LOT # 16B06G8301 AND 15L10G8274. WE HAD A TOTAL OF FOUR DIFFERENT COMPLAINTS FROM FOUR DIFFERENT EMS PROVIDERS REGARDING THESE LOT NUMBERS. I WAS BEING TOLD THAT ONCE THE IV WAS ESTABLISHED. THE PROVIDERS WERE ADVANCING THE CATHETER AND WHEN WITHDRAWING THE NEEDLES THE SAFETY SPRING/GUARD WOULD GET STUCK INSIDE OF THE CATHETER HUB. THIS RESULTED IN THE CATHETER HAVING TO BE REMOVED FROM THE PATIENT AND THE IV RE-ESTABLISHED." NO INJURY. NO SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690441 INTROCAN SAFETY® I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1