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

Model Number	B2-70072
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported to intuvie that the back check valve failed, causing chemotherapy and other medications on a secondary set to flow back into the primary line.On (b)(6) 2025, the customer provided follow-up information stating: ¿we actually had one do it today while infusing taxol.Unfortunately, we are not sure which lot number of the two we used today.The two possible lot numbers are (b)(4) 25045349 and (b)(4) 25045698.I do not have a picture of the setup since it contained patient information.¿ a lot review performed for lot 25045349 and lot 25045698 revealed no similar complaints.The complaint could not be confirmed, and the probable cause remains unknown.Lot number 25045698.D4: suspected device expiration date: april 27, 2028.H4: device manufacture date: april 28, 2025.(b)(4).
Event or Problem Description
It was reported to intuvie that the back check valve failed, causing chemotherapy and other medications on a secondary set to flow back into the primary line.On november 25, 2025, the customer provided follow-up information stating: ¿we actually had one do it today while infusing taxol.Unfortunately, we are not sure which lot number of the two we used today.The two possible lot numbers are (b)(4) 25045349 and (b)(4) 25045698.I do not have a picture of the setup since it contained patient information¿.No patient or user harm was reported.
Additional Manufacturer Narrative
The tubing was not returned for evaluation.Therefore, the complaint could not be confirmed, and the probable cause remains unknown.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: 23881318
• Report Number: 3006575795-2025-00802
• Device Sequence Number: 9623019
• Product Code: FPA
• UDI-Device Identifier: 10814371020195
• UDI-Public: 10814371020195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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 Expiration Date: 11/28/2025
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 25045349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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