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

Model Number	B2-70071-D
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available, the reported leak may be associated with factors external to the device, such as handling conditions.During follow-up, the user indicated that previously observed leaking iv tubing may have been related to handling practices (i.E., placement of bags in plastic chemotherapy bags prior to use) and reported that no recent issues have occurred.Multiple attempts were made to obtain additional information and request return of the affected product; however, no tubing or device was returned and no lot number or additional traceable information was provided, limiting the ability to perform a device-specific or lot-level investigation.The model number b2-70071-d was provided by the reporter.A review of historical complaints identified reports of iv set leakage, which are currently being evaluated under an active capa.These events were associated with specific, identified conditions and/or locations.As the current complaint did not include sufficient detail regarding the nature or location of the reported leak, a direct correlation to known failure modes could not be established.While the available information suggests a potential association with handling conditions and/or ancillary iv tubing, a device-related issue cannot be definitively ruled out due to the absence of returned product and limited information.No adverse event or patient injury was reported.
Event or Problem Description
A customer reported that a batch of iv tubing in use was faulty and leaking during infusion.The reporter indicated that after switching to a new batch of tubing, the issue was no longer observed and subsequent infusions were completed successfully.No adverse event or patient injury was reported in association with this issue.

• Brand Name: ZYNO
• Common Device Name: SET, ADMINISTRATION
• 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: 25032420
• Report Number: 3006575795-2026-01120
• Device Sequence Number: 9175697
• Product Code: FPA
• UDI-Device Identifier: 10814371020157
• UDI-Public: 10814371020157
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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 Model Number: B2-70071-D
• Device Catalogue Number: B2-70071-D
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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