BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN SAFETY®

    MDR report key: 24625884 · Received March 18, 2026

    Report

    Report Number
    9610825-2026-00140
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    July 17, 2025
    Report Date
    May 13, 2026
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    DYB
    Adverse Event
    Yes
    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). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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 # K021094, K220626.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). SAMPLE EVALUATION: RECEIVED 1 USED AND CONTAMINATED SAMPLE OF AN INTROCAN SAFETY PUR 24G, 0.7 X 19 MM-SA IN AN OPENED PACKAGING FOR LOT NUMBER 24K30G8913 AND MATERIAL # 4251601-04. THE CAPILLARY HUB WAS NOT RETURNED FOR INVESTIGATION. UPON RECEIPT, THE SAFETY CLIP HAD ENGAGED AND COVERED THE CANNULA TIP. MEASUREMENT: EVALUATION OF THE RETURNED SAFETY CLIP HOLE SHOWED NO VISIBLE ABNORMALITIES. THE CANNULA OUTER DIAMETER WAS MEASURED NEAR THE CRIMP AREA, AT THE MID SECTION, AND NEAR THE CANNULA HUB, AND ALL MEASUREMENTS MET THE APPLICABLE SPECIFICATIONS. REVIEWED THE IN-COMING SAFETY CLIP INSPECTION DATA: THE STAMPING IN-PROCESS QC DATA FOR THE CLIP BATCHES USED IN THE COMPLAINT BATCH 24K30G8913 SHOWED NO DEVIATION. ALL MEASUREMENTS OF THE CLIP HOLE SIZES WERE WITHIN THE SPECIFICATION. REVIEW OF IN-COMING CANNULA INSPECTION DATA: THE CANNULA PROCESSING IN-PROCESS QC DATA FOR THE CANNULA BATCHES USED IN THE COMPLAINT BATCH SHOWED NO DEVIATION. ALL MEASUREMENTS OF THE CANNULA OUTER DIAMETER AND CANNULA SURFACE ROUGHNESS WERE WITHIN THE SPECIFICATION. SIMULATION OF CLIP FUNCTION: THE RETURNED CONTAMINATED CANNULA SAMPLE WAS REASSEMBLED WITH A NEW INTROCAN G24 CATHETER HUB TO SIMULATE POTENTIAL SAFETY CLIP FAILURE. DURING THE SIMULATION, THE SAFETY CLIP OF THE RETURNED CONTAMINATED SAMPLE WAS OBSERVED TO ENGAGE SUCCESSFULLY AND FULLY COVER THE CANNULA TIP. CONCLUSION: INSPECTION OF THE RETURNED COMPLAINT SAMPLE DID NOT IDENTIFY ANY DAMAGE OR OTHER ABNORMALITIES. BASED ON THE SIMULATION PERFORMED, THE SAFETY CLIP ON THE RETURNED CANNULA WAS OBSERVED TO ENGAGE SUCCESSFULLY AND FULLY COVER THE CANNULA TIP. NO EVIDENCE OF A LOOSE SAFETY CLIP OR SAFETY CLIP DISLODGEMENT WAS OBSERVED DURING THE SIMULATION. AS NO DEVIATION WAS OBSERVED, THIS COMPLAINT IS NOT CONFIRMED. 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 INFORMATION: UDI NUMBER: (B)(4). PREMARKET SUBMISSION #: K021094, K220626.

    Description of Event or Problem · 0

    ACCORDING TO THE COMPLAINANT: "WHILE PERFORMING A PUNCTURE ON A PATIENT USING A #24 JELCO CATHETER, AN EMPLOYEE, UPON PULLING THE NEEDLE (GUIDE), FAILED TO NOTICE THAT THE SAFETY MECHANISM THAT SHOULD HAVE BEEN OBSTRUCTING THE NEEDLE TIP HAD MALFUNCTIONED, LEAVING IT EXPOSED. THIS RESULTED IN A WORKPLACE ACCIDENT WHEN THE EMPLOYEE PRICKED HIS LEFT HAND WITH THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610820 INTROCAN SAFETY® INTRODUCER, CATHETER DYB B BRAUN MELSUNGEN AG 24K30G8913

    Patients

    Seq Age Sex Outcome Treatment
    1