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

Catalog Number	4242004-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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.
Event or Problem Description
As reported by the user facility: reason of complaint: 22g introcan safety2 when sytlet removed, blood control septum was attached to the stylet and safety mechanism did not engage.Patient injury no.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) photo and one (1) sample were submitted to the manufacturer for evaluation.Through visual examination of the photo, the septum opener was observed to be detached and stuck at the middle section of the cannula.Through visual examination of the received sample, the septum opener had detached from the catheter hub and attached together with the safety clip.The safety clip was observed to not be engaged until the cannula tip.Additionally, the cannula was in a bent condition.The sample is not within specification; the reported issue is confirmed.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.The defect is due to a failure in the production process.An approved project is in place to further address issues with detached septum.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: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23357812
• Report Number: 9610825-2025-00615
• Device Sequence Number: 8815911
• Product Code: FOZ
• UDI-Device Identifier: 04046955745869
• UDI-Public: (01)04046955745869(11)250225(17)300201(10)25B25G8274
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/22/2025

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: 4242004-02
• Device Lot Number: 25B25G8274
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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