BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN®

    MDR report key: 19267930 · Received May 8, 2024

    Report

    Report Number
    9610825-2024-00335
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 9, 2024
    Report Date
    July 9, 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. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR THE COMPLAINT BATCH 23A28G8263 AND NO ABNORMALITY WAS OBSERVED DURING IN-PROCESS AND AT FINAL CONTROL INSPECTION. SAMPLE FOR EVALUATION: RECEIVED 1 USED AND CONTAMINATED CAPILLARY HUB OF AN INTROCAN FEP W G22/25 CN WITHOUT PACKAGING. VISUAL INSPECTION OBSERVED THE CAPILLARY HAD CUT OFF NEAR THE CAPILLARY HUB HORN. OBSERVED A STRAIGHT AND CLEAN CUT. THE CUT OFF PIECE WAS NOT RECEIVED. REFERENCE TO IFU: 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SECTION STATED THAT: - NEVER REINSERT THE NEEDLE INSIDE THE CATHETER ONCE THE NEEDLE HAS BEEN PARTIALLY OR COMPLETELY WITHDRAWN AS IT MAY PIERCE AND/OR SEVER THE CATHETER.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. REVIEW ASSEMBLY PROCESS: THE INTROCAN PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH VISION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS A 100% INSPECTION STATIONS TO CHECK THE PRESENCE AND CONDITION OF CATHETER TIP, TRIM LENGTH, BEVEL AND CONTOUR. PRODUCTS DETECTED OUT OF THE INSPECTION CRITERIA WILL BE DETECTED AND BE REJECTED BY MACHINES AUTOMATICALLY. ALL THE IN-LINE TEST EQUIPMENT IS SUBJECT OF A FREQUENT CALIBRATION AND A REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HERE WITH POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IN TIME AND WOULD BE MITIGATED IMMEDIATELY. THE PROCESS CARDS FOR THE COMPLAINT BATCH SHOW NO ABNORMALITY. CONCLUSION: THIS DEFECT IS NOT DUE TO MANUFACTURING PROCESS AND MOSTLY LIKELY DUE TO APPLICATION ERROR. COMPLAINT IS NOT CONFIRMED.

    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 CUSTOMER WHEN THE LEFT CEREBRAL ARTERY PUNCTURE NEEDLE WAS PULLED OUT AFTER SURGERY, IT WAS FOUND THAT THE CAPILLARY WAS BROKEN, AND THE ANTERIOR PART OF THE CAPILLARY REMAINED IN THE PATIENT'S BODY. THE SURGEON PERFORMED A SURGICAL INCISION OF 10 CENTIMETERS (CM) ON THE SKIN OF THE ARM, REMOVED THE BROKEN CAPILLARY, COMPARED IT WITH THE INTACT CATHETER, AND REMOVED THE COMPLETE PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141362 INTROCAN® CATHETER,INTRAVASCULAR FOZ B BRAUN MELSUNGEN AG 4254090B 23A28G8263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention