MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FLUID DISPENSING CONNECTOR; DISPENSER, LIQUID MEDICATION

Catalog Number	415080
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: reporting a green shaving from fluid dispensing connector (ref 415080) that was loose and transferred into a sterile syringe for patient use.
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) syringe filled with drug was provided for evaluation.Upon visual evaluation of the sample, it was observed that the syringe contained a loose green component within the fluid path.The sample was subsequently submitted to the analytical laboratory for material identification using the ftir.Analysis indicated that the green component closely resembled or is consistent with material 415080 (fdc1000 fluid dispensing connector).Based on the investigation finding, the reported defect was confirmed.Based on the evaluation of the returned sample and the analytical laboratory test report, the loose green piece found within the syringe's fluid path closely resembles material 418050 - fdc1000 fluid dispensing connector.Although the foreign material has been associated with this component, the exact root cause cannot be conclusively determined at this time.This product is recommended to be used in accordance to the instruction for use (ifu) which states, "use aseptic technique.Visually inspect sterile barrier system for breaches and integrity prior to use.Do not use if packaging or product is damaged or contaminated or if protective caps are loose or missing.Use of damaged or contaminated device might lead to injury, illness, or death of the patient." these ifu requirements emphasize the importance of verifying device and packaging integrity prior to use to prevent contamination or the introduction of foreign material into the fluid path.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.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: FLUID DISPENSING CONNECTOR
• Common Device Name: DISPENSER, LIQUID MEDICATION
• 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: 24285785
• Report Number: 2521402-2026-00091
• Device Sequence Number: 18215180
• Product Code: KYX
• UDI-Device Identifier: 04022495820105
• UDI-Public: (01)04022495820105(11)250707(17)300630(10)0062016760
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K800437
• 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: 415080
• Device Lot Number: 0062016760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/07/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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