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

Model Number	B2-70071-DF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Intuvie received a report indicating that right way medical received a complaint stating, ¿the filter tubing i used today had a crack in it, which eventually caused some medication to spray out.¿ the packaging was reported to be intact when the nurse opened the tubing set.The filter began leaking approximately two hours into the infusion.Gammagard s-d was being infused at the time of the event.The device was not returned for evaluation.Therefore, the probable cause could not be determined.No patient or user harm was reported.
Additional Manufacturer Narrative
Intuvie received a report indicating that right way medical received a complaint stating, ¿the filter tubing i used today had a crack in it, which eventually caused some medication to spray out.¿ the packaging was reported to be intact when the nurse opened the tubing set.The filter began leaking approximately two hours into the infusion.Gammagard s-d was being infused at the time of the event.A review of the device lot history did not identify any similar complaints.The device was not returned for evaluation.Therefore, the probable cause could not be determined.Reference to complaint#: (b)(4).

• Brand Name: ZYNO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR 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: fred lee ; 177 pine street; natick, MA 01760 ; 5086502007
• MDR Report Key: 23597336
• Report Number: 3006575795-2025-00722
• Device Sequence Number: 10291278
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 10/21/2025
• Device Model Number: B2-70071-DF
• Device Catalogue Number: B2-70071-DF
• Device Lot Number: 22105613
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2022
• 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