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

Catalog Number	4252527-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility: catheter broken off.Description - piece of the catheter broke off in the patients arm and had been surgically removed.Patient was admitted to the hospital (b)(6) 2023 which iv was started.On (b)(6) 2023 iv was removed once patient was released from hospital, he was sent home and the place the iv was got infected.They had an ultrasound done and found a piece of the catheter in his basilic vein (right arm).On (b)(6) 2023 surgery was performed to remove the broken piece.Patient was okay.Male 61 unable to verify which catheter broke off.Part numbers listed are 4252527-02 & 4251652-02 in patient record.As part of an internal nonconformance, this importer mdr is being submitted retroactively.Please note that the associated manufacturer mdr for this event, 9610825-2023-00612, had already been previously submitted timely on 18dec2023.As b.Braun medical, inc.Submitted the manufacturer mdr on behalf of the manufacturer, the importer mdr was inadvertently missed.

• 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 strabe 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 25563378
• Report Number: 2521402-2026-00661
• Device Sequence Number: 10077615
• Product Code: FOZ
• UDI-Device Identifier: 04046963318185
• UDI-Public: (01)04046963318185
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026
• Report Date (Section F): 12/18/2023

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 Catalogue Number: 4252527-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/18/2023