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

Catalog Number	490103
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: "arrived at bedside for report and upon dual signing fluids and tracing iv tubing, noticed that large bore iv tubing running clear kvo fluids was dripping.Traced drip back to its origin.Tubing noted to have a crack on both sides.Site of crack was just distal to iv pump and iv tubing insertion but far from patient and crib.Air also noted in line at this time.Tubing removed and new tubing with new bag of fluid hung.".
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One used sample without packaging was submitted for evaluation.The sample was visually evaluated, when compared to the drawing the sample did not match the reported material (490100).The material received is 490103, space pump iv set w/2 caresite, ckvlv.The sample was then leak tested and leakage was detected in the tubing between the proximal side of the space pump segment and the roller clamp.Further evaluation showed a cut in tubing.This cut was the source of the air bubbles observed in the iv set.An exact root cause could not be determined at this time.It should be noted that a review of our manufacturing and hand assembly processes identified no sharp objects or steps that could produce damage of this nature.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.

• 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: 24650336
• Report Number: 2521402-2024-00284
• Device Sequence Number: 9797386
• 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): 03/20/2026

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: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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