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

Model Number	BX-70071-D
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event is part of a retrospective review associated with a correction implemented under capa-32 and is being reported late.It was reported to intuvie that the vent cover detached when attempting to open it during administration of intravenous immunoglobulin (ivig).No additional information was provided.A review of the lot history for lot 2309065 revealed no similar complaints.The iv set tubing was not returned to intuvie for evaluation.The complaint could not be confirmed, and the probable cause could not be determined.Reference to complaint #: (b)(4).
Event or Problem Description
It was reported to intuvie that ¿the vent cover falls off when trying to open it when giving intravenous immunoglobulin (ivig)¿.No other information was provided.No patient or user harm was reported.

• Brand Name: ZYNO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 23871689
• Report Number: 3006575795-2025-00781
• Device Sequence Number: 17277855
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: (01)00814371020532(17)260924(10)2309065
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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 Expiration Date: 09/24/2026
• Device Model Number: BX-70071-D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 2309065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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