MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B.BRAUN; SET, I.V. FLUID TRANSFER

Catalog Number	2112550
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was returned for evaluation.The returned sample was visually evaluated by subject matter experts (smes) for conformance to the product drawing and all applicable visual requirements.Inspection of flex lines four (4) and five (5) confirmed that both the macro and micro leads on each line were properly attached to their corresponding manifold ports.Each lead was also verified to be correctly labeled with the appropriate flag number.The remaining leads were inspected and confirmed to be attached to the correct ports based on flag identification.A final visual inspection was performed in accordance with the final product specification, and no visual defects were identified.The retain sample was visually inspected per specification, and no defects were observed.The reported defect is not confirmed.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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: leads mislabeled.Upon installing txs on pump module customer noticed tubing 4 was labeled as 5 and tubing 5 was labeled as 4.No patient involvement.

• Brand Name: B.BRAUN
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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 avenue; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 25028277
• Report Number: 2521402-2026-00449
• Device Sequence Number: 9176094
• Product Code: LHI
• UDI-Device Identifier: 04046964656101
• UDI-Public: (01)04046964656101(11)251230(17)271130(10)0062037762
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K151423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 2112550
• Device Lot Number: 0062037762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/30/2025
• 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