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

Model Number	BX-7001-D
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intuvie that ¿lot 2404016 has been reported to contain more air bubbles than usual¿.No other information was provided.No patient or user harm was reported.A review of the lot# history for lot 2404016 revealed no similar complaints.The iv set tubing was not returned to intuvie for evaluation.The complaint was confirmed; however, the probable cause could not be determined.
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 ¿lot 2404016 has been reported to contain more air bubbles than usual¿.No other information was provided.No patient or user harm was reported.A review of the lot# history for lot 2404016 revealed no similar complaints.The iv set tubing was not returned to intuvie for evaluation.The complaint was confirmed; however, the probable cause could not be determined.Reference to complaint # (b)(4).

• 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: 23880127
• Report Number: 3006575795-2025-00794
• Device Sequence Number: 21238312
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• 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): 12/23/2025

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-7001-D
• Device Catalogue Number: BX-7001-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: 12/23/2025
• Date Device Manufactured: 09/25/2023
• 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