MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. UNIVERSAL 60 DROP NITRO PUMP SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	490037
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
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: during preparation the set was noted to have the green clip backwards so couldn't load tubing.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample without packaging was provided for evaluation.The sample was visually evaluated and compared against the product technical drawing and the returned sample corresponds to material 490037.The slide clamp was also assessed and found to be within specification.Upon receipt, the sample arrived with the air vent open.The air vent was subsequently closed, and a leakage test was performed; no leakage was detected.To replicate the reported air in line alarm defect, the returned sample was connected to the pump without difficulty and tested by running therapy while varying the flow rate throughout the session.No alarms were observed during testing.Thereafter, a measurement of the outer diameter of the pump segment was taken and found to be 0.152 inches, which meets the specification of 0.152-0.154 inches.Based on the investigation findings, the sample met internal specification; therefore, the reported defect could not be confirmed.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.Additionally, the retained units were evaluated and passed the internal testing.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: UNIVERSAL 60 DROP NITRO PUMP SET
• 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: 24035716
• Report Number: 2521402-2025-01666
• Device Sequence Number: 18394964
• Product Code: FPA
• UDI-Device Identifier: 04046964294617
• UDI-Public: (01)04046964294617
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 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): 02/05/2026

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: 490037
• Device Lot Number: 0062011343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/05/2026
• 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