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

Catalog Number	413501
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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: dispensing pin had particulate matter in the cap of the dispensing pin.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) unused sample in open packaging was provided for evaluation.Evaluation of the sample revealed the presence of a foreign particle at and near the spike tip.Based on the investigation finding, the sample was not within internal specification; therefore, the reported defect was confirmed.The sample was submitted to the laboratory for evaluation of foreign material located on the tip of the spike.The sample was analyzed using ftir in accordance with specified procedure and the atr attachment.The scan was then compared against the material directory to identify the closest match.A correlation coefficient of greater than or equal to 0.8000 indicated that two materials are considered similar or matching.The scan of the unknown material was compared to the directory, and the highest correlation value obtained was 0.4194, which does not meet the acceptance criteria.Based on this result, the composition of the foreign material could not be determined.It is possible that the sample size was insufficient to produce an accurate ftir reading.Therefore, the exact root cause could not be determined at this time.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, a historical review of the customer complaint database dating back one year revealed no trends/ similar complaints of this nature against this finished lot number.Therefore, no formal corrective action is warranted at this time.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: DISPENSING PIN
• 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 ave; bethlehem, PA 18018 ; 8334251464
• MDR Report Key: 24258737
• Report Number: 2521402-2026-00096
• Device Sequence Number: 15486691
• Product Code: LHI
• UDI-Device Identifier: 04022495769756
• UDI-Public: (01)04022495769756(11)251008(17)300930(10)0062037148
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 413501
• Device Lot Number: 0062037148
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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