BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN®-W

    MDR report key: 19319174 · Received May 15, 2024

    Report

    Report Number
    9610825-2024-00402
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    April 7, 2024
    Report Date
    July 10, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. ROOT CAUSE ANALYSIS: REVIEW OF THE PROCESS CARDS SHOW NO ABNORMALITIES. TRENDING ANALYSIS: CUSTOMER COMPLAINT OF CAPILLARY DAMAGE - TEAR OFF FOR INTROCAN TREND ANALYSIS IS BEING TRACKED BASED ON CAPA INITIATION CRITERIA. SUMMARY OF ROOT CAUSE ANALYSIS: · RECEIVED 1PC USED SAMPLE OF INTROCAN-W FEP 18GX1 3/4", 1,3X45MM IN AN OPENED PACKAGING. NO PROTECTIVE CAP RETURNED FOR INVESTIGATION. · THE SAMPLE WAS TAKEN FOR INVESTIGATION AND OBSERVED THE CAPILLARY WAS TEAR APPROXIMATELY 34MM FROM THE CAPILLARY HORN AREA. · THE TEAR OFF PIECE OF THE CAPILLARY WAS RETURNED FOR INVESTIGATION. THE LENGTH OF THE TEAR OFF PART WAS MEASURED AT 11MM. · OBSERVATION ON THE TEAR OFF SURFACE SHOWS A [?]V' CUT SHAPE WHICH IS BELIEVE THE SAMPLE WAS PIERCED BY CANNULA. MANUFACTURING PROCESS WAS REVIEWED AND THERE ARE DETECTION FOR CAPILLARY TIP DAMAGE AT CAL AND ECM MACHINE VISION SYSTEM, THE STATION IS HIGHLIGHTED IN BELOW PROCESS FLOW. SIMULATION 1: SIMULATION 1 WAS CONDUCTED BY CUTTING A CAPILLARY TO A SHORTER LENGTH AND TEST AT BOTH CAL AND ECM MACHINE VISION SYSTEM. THE SAMPLE WAS ABLE TO BE DETECTED AND WAS REJECTED. SIMULATION 2: SIMULATION 2 WAS CONDUCTED BY PURPOSELY TRY TO BREAK OFF THE CAPILLARY UNDER DIFFERENT SCENARIOS. SCENARIO 1 - PIERCE BY CANNULA · A SIMULATION WAS CONDUCTED BY PIERCING THE CAPILLARY WITH CANNULA AND PULL OFF THE CAPILLARY APART AND COMPARE THE DEFECT CREATED WITH THE COMPLAINT SAMPLE. · THE SIMULATION SAMPLE EXHIBITS A "V" SHAPE CUT AT THE CAPILLARY BROKEN AREA AS A RESULT OF BEING CUT BY THE CANNULA BEVEL. · THE DEFECT CREATED SIMILAR TO COMPLAINT SAMPLE. COMPARISON OF COMPLAINT SAMPLE VS SIMULATION SAMPLE SCENARIO 2 - CUT BY SCISSORS · A FEW GOOD SAMPLES OF CAPILLARY WERE CUT BY SCISSORS AND THE SAMPLES WERE TAKEN FOR INSPECTION. · THE CUT AREA SHOWING A CLEAN CUT OF THE CAPILLARY. · THE DEFECT CREATED IS NOT SIMILAR TO THE COMPLAINT SAMPLE. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: · NEVER REINSERT THE NEEDLE INSIDE THE CATHETER ONCE THE NEEDLE HAS BEEN PARTIALLY OR COMPLETELY WITHDRAWN AS IT MAY PIERCE AND/OR SEVER THE CATHETER. · EXTREME CARE SHOULD BE TAKEN NOT TO DAMAGE, PIERCE, CUT OR SEVER THE CATHETER. THEREFORE, DO NOT BEND THE CATHETER AND/OR NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. · DO NOT USE SCISSORS OR SHARP INSTRUMENTS AT OR NEAR THE INSERTION SITE. CONCLUSION: 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. 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. TEAR OFF CAPILLARY MOST LIKELY NOT APPEAR TO BE ATTRIBUTED BY MANUFACTURING PROCESS AS THE DEFECT IS ABLE TO BE DETECTED AND REJECT BY THE IN-LINE VISION SYSTEM. DAMAGES INDUCED AFTER ASSEMBLY PROCESS IS NOT POSSIBLE SINCE THE CATHETER HAD BEEN PROTECTED WITH PROTECTIVE CAP. BASED ON THE INVESTIGATION ABOVE, THIS DEFECT IS BELIEVED TO BE CAUSED BY REINSERTING THE CANNULA INTO CAPILLARY WHICH LEAD TO THE CAPILLARY BEING PIERCED AND LATER GOT TEAR OFF DURING WITHDRAWAL. CAUSE: DEFECT DUE TO WRONG HANDLING.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT ON APRIL 07 2024 AT 8:30 IN THE MORNING, A MEDIAN ELBOW VEIN PUNCTURE WAS ESTABLISHED FOR THE PATIENT. WHEN BLOOD RETURNED, THE CAPILLARY WAS PUSHED. THE PUSHING PROCESS WAS NOT VERY SMOOTH, SO THE STEEL NEEDLE WAS INSERTED INTO THE BLOOD VESSEL. THE REMAINING 1 CENTIMETER (CM) WAS NOT FULLY INSERTED, AND THE INFUSION SET WAS CONNECTED TO FULLY INSERT THE REMAINING 1 CENTIMETER (CM) STEEL NEEDLE INTO THE BLOOD VESSEL. WHEN THE INFUSION SET WAS OPENED, ANY LEAKAGE WAS FOUND, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED. DISCOVERED ABNORMALITIES IN THE CAPILLARY WITH A 1 CENTIMETER (CM) MISSING FRONT END, IMMEDIATELY REPORTED TO THE HEAD NURSE. THE HEAD NURSE INFORMED THE SURGEON AND TOUCHED THE PUNCTURE POINT, INDICATING A FOREIGN BODY SENSATION UNDER THE SKIN. THE GENERAL SURGEON USED A NO.11 BLADE TO CUT OPEN THE SKIN BY ABOUT 0.3 MILLIMETER (MM), AND FOUND A BROKEN TUBE. THE BROKEN CAPILLARY WAS REMOVED WITH A PLEATED FORCEPS, AND A SUTURE WAS USED TO SEW A NEEDLE AND COVER THE WOUND WITH A PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546951 INTROCAN®-W IV CANNULAE FOZ B BRAUN MELSUNGEN AG 4254139B 22L22G8241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention