MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER

Catalog Number	4251131-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasculitis (2004)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event description, "patient inter to uci with septic disruptive shock, tri-valvular insufficiency, urinary tract infection and renal failure have phlebitis at the site of the punction.".
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.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Received fifty (50) pieces of unused introcan safety 3 pur 18g 1.3x32mm-sa in original packaging for lot number 24a02g8372 and material number 4251131-04.The returned samples were subjected to packaging integrity test, product functional tests i.E.Penetration force and gliding force and bacterial endotoxin test.All samples in original packaging passed for all tests.As no abnormality observed from the returned samples, 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.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER
• 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: 22097266
• Report Number: 9610825-2025-00303
• Device Sequence Number: 20704704
• Product Code: FOZ
• UDI-Device Identifier: 04046964014055
• UDI-Public: (01)04046964014055(11)240102(17)290101(10)24A02G8372
• Combination Product (Y/N): Y
• Initial Reporter Country: EC
• PMA/510(K) Number: K111236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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
• Device Catalogue Number: 4251131-04
• Device Lot Number: 24A02G8372
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown