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

Model Number	4251644-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Granuloma (1876)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are 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.
Event or Problem Description
According to the event description: client underwent surgery at (b)(6) on (b)(6) 2023 and was discharged from hospital on (b)(6) 2023.Client consulted the angiology and vascular surgery department at the (b)(6) due to a nodular formation on the left arm.The (b)(6) medical report referred to the presence of a foreign body, highly suggestive of a fragment of an intravenous catheter.Excision was carried out at (b)(6) on (b)(6)2024 and the nature of the material, approximately 5mm long, was confirmed.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).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.Complaint description: the situation described a presence of a foreign body, highly suggestive of a fragment of an intravenous catheter.Excision was carried out and the nature of the material, approximately 5mm long, was confirmed.Device history record (dhr): unable to review as batch is unknown.Evidence at disposal: no sample received and no picture available for a proper evaluation.Manufacturing control: products are subjected to in-process quality control and final controls inspection based on random samples.These personnel perform visual inspection to ensure products are free from all types of contaminations and no particles such as particles, fibers, hair or oil stain is allowed conclusion: as no sample was received, further investigation was not possible.Complaint is not confirmed.This complaint has been added into the statistic for trend analysis.

• 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 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: 21449432
• Report Number: 9610825-2025-00048
• Device Sequence Number: 7761605
• Product Code: FOZ
• UDI-Device Identifier: 04046963166007
• UDI-Public: (01)04046963166007
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 04/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4251644-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown