MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; CATHETER,INTRAVASCULAR,THE

Catalog Number 4251652-02

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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.

Event 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 8/18/2023 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.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18347165
• MDR Text Key: 330790592
• Report Number: 9610825-2023-00613
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963185206
• UDI-Public: (01)04046963185206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 4251652-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male