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

Catalog Number	490103
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample used without packaging was returned for evaluation.The sample was visually inspected and subjected to piggyback testing, where it was connected to an infusion pump operating at a flow rate of 299 ml/hr for fifteen minutes.Concurrently, a secondary iv bag containing green dye was attached to detect any backflow at the distal backcheck valve.No backflow was observed during the test.The sample was gravity primed, and no occlusion was detected.Additionally, no alarms were triggered throughout the investigation.The defect reported is not confirmed.Based on the sample evaluation, the product met internal specifications, and no product deviation was identified.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
As reported by the user facility: new piv lines primed with d10w while replacing the bag.At about 0600 bedside rn noticed iv bleeding back.Resource rn called to bedside.All line clamps and pump settings checked.Found part of line with air in it above the filter, and air in the quad-set close to patient.Filter was found with fluid in it.Bedside rn primed the line prior to placement.Patient iv unhooked from line and flushed with no difficulty.Iv remained intact.Replaced line.Care resumed.No specific crack in the line found.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• Manufacturer Contact: elena reifenstein ; 824 12th ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25097406
• Report Number: 2521402-2026-00468
• Device Sequence Number: 5005291
• Product Code: FPA
• UDI-Device Identifier: 04046964302107
• UDI-Public: (01)04046964302107
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: 490103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/06/2026
• 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
• Patient Sex: Unknown