BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTROCAN SAFETY®

    MDR report key: 21655169 · Received March 20, 2025

    Report

    Report Number
    9610825-2025-00137
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 19, 2025
    Report Date
    April 22, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K020785, K220626, K021094. DEVICE HISTORY RECORD (DHR): REVIEWED THE DEVICE HISTORY RECORD FOR BATCH NUMBER 24G20G8392 AND THERE WERE NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. COMPLAINT DESCRIPTION: THE SITUATION DESCRIBED OF A WORK ACCIDENT WHERE THE ABOCATH SAFETY DEVICE WAS NOT ACTIVATED WHEN REMOVING THE GUIDE AT THE TIME OF PUNCTURE. EVIDENCE AT DISPOSAL: NO SAMPLE RECEIVED BUT TWO PHOTOS WERE PROVIDED FOR EVALUATION. PICTURE 1, FLASHBACK OF BLOOD IN THE FLASHBACK CHAMBER WAS OBSERVED. THE SAFETY CLIP POSITION WAS OBSERVED TO BE LOCATED NEAR TO CANNULA HUB IN WHICH THE SAFETY CLIP DID NOT ENGAGE AT THE CANNULA TIP AFTER CANNULA WITHDRAWAL FROM THE CATHETER HUB. PICTURE 2, A PEEL PACK OF INTROCAN SAFETY PUR 20G, 1.1X32MM-SA FROM BATCH 24G20G8392 AND ARTICLE# 4251644-04 WAS OBSERVED. THE ACTUAL CONDITION OF THE COMPLAINT SAMPLE (CANNULA SURFACE CONDITION, CLIP CONDITION, CANNULA HUB CONDITION, CATHETER HUB CONDITION AND ANY OTHER DAMAGES) ALSO CANNOT BE IDENTIFIED FROM THESE PICTURES. REVIEWED INCOMING SAFETY CLIP INSPECTION DATA: THE STAMPING IPQC DATA FOR THE CLIP BATCHES USED IN THE COMPLAINT SAMPLE SHOWED NO DEVIATION AND ALL MEASUREMENTS WERE WITHIN THE SPECIFICATION. REVIEWED ASSEMBLY PROCESS: THIS PRODUCT IS ASSEMBLED ON AUTOMATED ASSEMBLY MACHINES EQUIPPED WITH 100% VISION INSPECTION SYSTEM AND TEST STATIONS. ALONG THE MACHINES, THERE IS 100% CHECKING ON THE CLIP CONDITION AND DEFECTIVE PARTS DETECTED OUT OF THE CHECKING CRITERIA WILL BE DETECTED AND BE REJECTED BY MACHINES. THE IN-LINE TEST EQUIPMENT IS ALSO SUBJECTED TO FREQUENT CALIBRATION AND REGULAR VERIFICATION RELATED TO ITS PROPER FUNCTION. HEREWITH, POTENTIAL MALFUNCTIONS OF THE SYSTEMS WOULD BE DETECTED IMMEDIATELY AND WOULD BE MITIGATED IMMEDIATELY. THE PROCESS CARDS FOR THE COMPLAINT BATCH WAS REVIEWED AND NO ABNORMALITY WAS OBSERVED. MANUFACTURING CONTROL: BESIDES THE IN-LINE TEST EQUIPMENT, PRODUCTS ARE SUBJECTED TO IN-PROCESS AND FINAL CONTROL INSPECTION BASED ON RANDOM SAMPLES BASIS. THE INSPECTION RECORD FOR THE COMPLAINT BATCH ON THE CLIP DRAG FORCE TEST SHOW 20 PCS SAMPLES WERE TESTED AND PASSED. CONCLUSION: ALL MANUFACTURING RECORDS FOR THE COMPLAINT BATCH SHOW NO ABNORMALITY. AS NO SAMPLE RECEIVED, FURTHER INVESTIGATION WAS NOT POSSIBLE TO DETERMINE THE ACTUAL CAUSE. AS PICTURE SHOWS THE SAFETY CLIP DID NOT ENGAGE AND COVER THE NEEDLE TIP, COMPLAINT IS 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 DEVICES ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # FOR SIMILAR DEVICE: (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "ON (B)(6) 2025 WE HAD A RECORD OF A WORK ACCIDENT WHERE THE ABOCATH SAFETY DEVICE WAS NOT ACTIVATED WHEN REMOVING THE GUIDE AT THE TIME OF PUNCTURE." "THE 54YEAR-OLD FEMALE EMPLOYEE, NOT PREGNANT. WHILE PROVIDING CARE TO THE PATIENT, SHE RETRACTED HER ARM AT THE TIME OF THE PUNCTURE. IN AN ATTEMPT TO STABILIZE THE PATIENT'S RETRACTION, THE EMPLOYEE REPORTS THE ACCIDENT WITH A SHARP OBJECT IN THE REGION OF HER RIGHT THUMB. THE SHARP OBJECT ACCIDENT PROTOCOL WAS THEN INITIATED, ACTIVATING THE CCIH AND UNDERGOING MEDICAL EVALUATION IN THE EMERGENCY ROOM OF HOSPITAL VILA VELHA. THE USER RECOVERED FROM THE ADVERSE EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451612 INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ B BRAUN MELSUNGEN AG 24G20G8392

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female