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

Catalog Number	B2-70072
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The b2-70072 tubing sets involved in the reported events were not available for investigation, as the customer discarded the products.Lot number information was not provided.As a result, an investigation of the tubing could not be performed.The complaint could not be confirmed, and the probable cause remains unknown.If additional information becomes available, a supplemental report will be submitted, as applicable.Reference to complaint#: (b)(4).
Event or Problem Description
On november 14, 2025, intuvie received a report from a customer stating that they were experiencing issues with b2-70072 tubing, specifically that the back check valve was failing, resulting in chemotherapy and other medications from a secondary set flowing back into the primary line.The customer reported that this issue had occurred at least 30 times, and possibly more, and described it as a significant concern.The events were reported to occur at various points during therapy, including immediately after connecting the secondary set and during the course of treatment.The customer indicated that the issue was not limited to a single box of tubing but had been observed across multiple boxes over the past several months.No patient harm was reported.On november 21, 2025, follow-up information was received from the customer, who reported multiple incidents in which the secondary infusion flowed into the primary fluid bag.The customer explained that the b2-70072 tubing set was loaded into the pump with the primary bag hanging on the pole, and when the secondary line was connected above the pump and lowered to back-prime the line, then rehung above the primary bag, fluid from the secondary infusion flowed backward into the primary line fluid bag.

• 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: 23795304
• Report Number: 3006575795-2025-00748
• Device Sequence Number: 10476943
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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 Catalogue Number: B2-70072
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown