BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN

    MDR report key: 20098332 · Received August 29, 2024

    Report

    Report Number
    9610825-2024-00678
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 27, 2024
    Report Date
    September 11, 2024
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 23M18G8921 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 USED AND CONTAMINATED INTROCAN CERTO PUR 20GX1 1/4", 1,1X32MM WITHOUT PACKAGING. THE CAPILARY HAD TORN OFF AND THE TEAR OFF PIECE WAS NOT RETURNED FOR INVESTIGATION. THE TEAR OFF SURFACE SHOWS A "V-SHAPE" CUT WHICH IS BELIEVE PIERCED BY CANNULA BEVEL. A BLOOD STOPPER WAS ATTACHED TO THE CATHETER HUB. THE CANNULA HUB AND PROTECTIVE CAP WERE NOT RETURNED. REFERENCE TO THE INSTRUCTION FOR USE (IFU): AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: - AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. - DO NOT BEND THE CATHETER/NEEDLE DURING INSERTION, ADVANCEMENT, OR REMOVAL OF THE NEEDLE. - EXTREME CARE SHOULD BE TAKEN NOT TO CUT THE CATHETER AND POSSIBLY CAUSE AN EMBOLISM. - IN THE CASE OF AN UNSUCCESSFUL IV START, REMOVE THE NEEDLE FIRST TO ACTIVATE SAFETY MECHANISM, THEN REMOVE CATHETER FROM PATIENT AND DISCARD BOTH. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION SYSTEM AND TEST STATIONS. ALONG THE MACHINE, THERE IS TRIM LENGTH, BEVEL AND CONTOUR CHECKING STATION. PARTS FOUND OUT OF THE INSPECTION CRITERIA WILL BE DETECTED AND REJECTED AUTOMATICALLY 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. THE PROCESS CARDS FOR THE COMPLAINT BATCH SHOW NO ABNORMALITY. CONCLUSION: CUT OFF CAPILLARY MOST LIKELY NOT APPEAR TO BE ATTRIBUTED BY MANUFACTURING PROCESS AS THE DEFECT IS ABLE TO BE DETECTED AND BE REJECTED BY THE IN-LINE VISION SYSTEM. DAMAGES INDUCED AFTER ASSEMBLY PROCESS IS NOT POSSIBLE SINCE THE CATHETER HAD BEEN PROTECTED WITH PROTECTIVE CAP.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME 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

    FROM THE COMPLAINT DESCRIPTION: NEEDLE BROKE INSIDE THE PATIENT; SHE REQUIRED SURGICAL INTERVENTION TO REMOVE THE FRAGMENT. NO FURTHER DAMAGE AFTER THE PROCEDURE. CUSTOMER MADE NOTIFICATION TO INVIMA, NUMBER TO BE CONFIRMED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793247 INTROCAN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ B. BRAUN MELSUNGEN AG 23M18G8921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention