MAUDE Adverse Event Report: B.BRAUN MELSUNGEN AG INTROCAN SAFETY ® 2; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4242006-02
Medical Device Problem Codes	Leak/Splash (1354); Reflux within Device (1522)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: during trial with sample product, the pre-op charge nurse states that when they withdrew the stylet from the hub, blood came out as if there was no blood control in the hub.No injury reported.
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.
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.It was noted that the cannula hub and protective cap were not returned for evaluation.Through microscopic examination using a keyence microscope, the valve was in a closed condition and no damages on the valve were observed.A simulation for valve function was performed.Assembled the returned catheter hub with a new cannula and performed liquid testing to verify valve function during and after cannula withdrawal.The returned catheter hub sample passed the test.No red dye solution leakage was observed from the catheter hub during or after cannula withdrawal.A review of the device history record (dhr) was performed for the reported lot number, and no abnormalities or non-conformances were noted during the in process or final product inspection.This product is assembled on automated assembly machines equipped with 100% vision inspection system and test stations.Herewith, all assembled parts would go through inspection at the septum position check station and septum leakage test station.Defective parts will be detected and rejected automatically by the machine.Based on the investigation, the reported issue could not be observed or replicated.The complaint is considered 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 ® 2
• 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: 24665389
• Report Number: 9610825-2026-00157
• Device Sequence Number: 5042288
• Product Code: FOZ
• UDI-Device Identifier: 04046955745944
• UDI-Public: (01)04046955745944(17)301101(10)25M05G8C31
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220756
• 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
• Report Date (Section B): 03/27/2026

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
• Device Catalogue Number: 4242006-02
• Device Lot Number: 25M05G8C31
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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