MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	BX-70071-D
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuvie received a report from mckesson indicating that a patient's iv tubing experienced a potential manufacturing defect at the y-site port, resulting in leakage and the loss of eight vials of remicade.The lot number is unknown.A gross visual inspection performed of the available tubing revealed no visible holes or cracks except at the y-site area.The device was not returned to intuvie for further evaluation.As a result, the failure mode could not be confirmed, and the probable cause remains undetermined.Reference to complaint numbers: (b)(4).
Event or Problem Description
Intuvie received a report indicating that the patient's iv tubing exhibited a manufacturing defect at the y-site port, which resulted in a leak.As a consequence of the defect, 8 vials of the medication remicade were lost due to leakage and could not be administered to the patient.No patient or user harm was reported.

• Brand Name: ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 22649875
• Report Number: 3006575795-2025-00291
• Device Sequence Number: 8798325
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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 Model Number: BX-70071-D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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