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 Codes	Detachment of Device or Device Component (2907); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description during the demonstration of the product the septum came out with needle/safety shield.The safety shield didn't clamp over tip of needle.
Additional Manufacturer Narrative
The report has been identified as b.Braun medical international 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) photo was submitted to the manufacturer for evaluation.Through visual examination of the photo, an introcan safety 2 wl cannula was observed with the septum opener and safety clip at the middle of cannula.The septum opener has detached from the catheter hub.The safety clip was present inside the septum opener.Both septum opener and safety clip stopped at the middle of cannula.The reported issue was observed.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.Manufacturing records and the assembly process cards were reviewed, no abnormality observed.The ipqc data for the clip batch used in the complaint batch showed no deviation and all measurements were within specification.The cannula data for the cannula batch used in the complaint batch showed no deviation and all measurements were within specification.While the reported issue was observed, an exact root cause could not be determined at this time.An approved project is in place to further address issues with septum dislodging.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 str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 22991954
• Report Number: 9610825-2025-00514
• Device Sequence Number: 8997080
• Product Code: FOZ
• UDI-Device Identifier: 04046955745869
• UDI-Public: (01)04046955745869(11)250228(17)300201(10)25B28G8272
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: Other
• Device Catalogue Number: 4242004-02
• Device Lot Number: 25B28G8272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• 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