MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4252543-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Please note: the reported lot number of 25c4g8302 does not validate in our system.Lot number is considered unknown until more information is gathered.
Event or Problem Description
As reported by the user facility: reason of complaint: iv catheter stick because safety mechanism failed.Patient injury: no.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Updated product information in section d4.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation.Through visual examination, it was observed that the safety clip had stopped near the cannula tip area and the safety clip was not activated to cover the cannula tip.The safety clip had dislodged at position before cannula crimped area.No damages and no deformities were observed on the safety clip long arm, clip short arm and clip backwall under x20 magnification.No damages and no dented areas were observed on both external and internal side of clip hole.However, it was observed that the clip travelled scratched lines on the cannula surface until the cannula tip area, indicating that the safety clip had travelled until the cannula tip.No dented or excess metal nodes observed on cannula surface.The safety clip dislodged condition was corrected back to original assembly condition for visual checking on any damage.The safety clip was removed from the stopped position to check the cannula surface.No damages no dents and no excess metal nodes were observed on the cannula surface where the safety clip stopped position.The cannula outer diameter was measured at three different sections (near crimp area, middle and near cannula hub) of cannula.The measurement passed and were within specification.The complaint cannula sample was inspected for cannula slanting condition with cannula slanting jig.The complaint cannula sample passed for cannula slanting test; no slanting was observed.Simulation was carried out by manually assembled the returned contaminated cannula with a fresh catheter hub sample of introcan safety g20x25 for verification of the clip function during cannula withdrawal.From the simulation, the safety clip of the returned contaminated sample was able to engage successfully and completely cover the cannula tip.A simulation was also performed on a fresh complete introcan safety g20x32 sample for possible clip dislodgement from cannula during cannula withdrawal.Cannula withdrawal performed at an angle (not following the instruction for use (ifu)) and with uncontrolled or quick motion, upon nearing cannula tip, the clip was able to engage and close the cannula tip, but the clip was scratched against inner catheter hub moment before the cannula was totally withdraw out from the catheter hub.This caused the clip to dislodge and become stuck at the cannula body.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformance's were noted during the in process or final product inspection.Based on the investigation, the returned sample was thoroughly inspection, measured and under simulation test, the safety clip was able to engage and cover the cannula tip.As no deviations were observed, the complaint is not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23656064
• Report Number: 9610825-2025-00650
• Device Sequence Number: 17349715
• Product Code: FOZ
• UDI-Device Identifier: 04046963185190
• UDI-Public: (01)04046963185190(11)250304(17)300301(10)25C04G8302
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4252543-02
• Device Lot Number: 25C04G8302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/15/2026; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown