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

Catalog Number	BC2000
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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
According to the complainant: on the right side of the plug there is also a gray element that was attached to it.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) addease binary connector attached to drug vial and pab bag, and one (1) photograph were provided for evaluation.Upon visual inspection of the photograph, a greyish foreign material was observed adjacent to the plunger.Additionally, upon receiving the sample, which was already assembled and activated, visual evaluation was conducted, revealing grey foreign matter inside the vial.Further assessment was performed by detaching the connector from the vial, which revealed that the vial stopper had a cut.The foreign matter identified inside the vial was attributed to this cut in the vial stopper.Based on the investigation findings, the reported defect was not confirmed to be a manufacturing-related defect.The presence of the foreign matter inside the vial was determined to be a result of damage to the vial stopper caused by excessive force during spiking.This damage generated particulate material from the stopper, which migrated into the vial.The issue was not attributed to a manufacturing defect but rather to improper technique during assembly.As outlined in the product's instructions for use (ifu), proper spiking technique is critical: "center addease spike inside the target of the medication vial and push straight down until addease latches firmly onto vial.To avoid potential for particulate matter or leakage, use a straight and continuous motion.Avoid excessive force." improper alignment or excessive force during spiking can compromise the stopper integrity, resulting in particulate contamination.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: ADDEASE®
• 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 ; 901 marcon blvd; allentown, PA 18109 ; 8334251464
• MDR Report Key: 23927467
• Report Number: 2521402-2025-01617
• Device Sequence Number: 8824877
• Product Code: LHI
• UDI-Device Identifier: 04046964186592
• UDI-Public: (01)04046964186592
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090905
• 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): 01/26/2026

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: BC2000
• Device Lot Number: UNKNOWN
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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