MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	V6223
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a 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 or Problem Description
Per uf/importer report # (b)(4): describe the event or problem: microbore extension set leaking at green hub while infusing dopamine.Patient experienced decreased arterial pressure.Patient required normal saline bolus, increased dopamine and increased epinephrine following this issue.What was the original intended procedure? medication infusion what problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working) therapies being used on the patient at the time of the event that may have caused or contributed to the event: cardiac drugs.Other information about the patient that may have influenced the outcome of the event: none other relevant history, including preexisting medical conditions: preexisting characteristics that may have contributed to the event: hypertension.

• Brand Name: EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21272905
• Report Number: 2523676-2025-00045
• Device Sequence Number: 19812375
• Product Code: FPA
• UDI-Device Identifier: 04046964189227
• UDI-Public: (01)04046964189227(11)240515(17)290515(10)0061938552
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K844719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: Health Professional
• Device Catalogue Number: V6223
• Device Lot Number: 0061938552
• 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: 01/09/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2024
• 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 Age: 12 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Race: Black Or African American