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

Model Number	BX-70070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received reports of leakage involving bx-70070 administration sets from lot 2502046.An rma (rma17137) was issued, and the leaking administration sets are being returned for evaluation.A lot history review of similar complaints identified one prior complaint.Device evaluation is pending receipt of the returned samples.A supplemental mdr will be submitted if additional or new information becomes available.Reference to complaint # (b)(4).
Event or Problem Description
The infusion specialist reported to intuvie that several bx-70070 administration sets from lot #2502046 appeared to be defective.The reporter experienced two issues on friday morning and one issue the previous thursday.The box was first opened the day prior to reporting.The administration sets were observed to be leaking from the bottom of the drip chamber.No patient or user harm was reported.No additional information was provided.

• 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: 23933982
• Report Number: 3006575795-2025-00821
• Device Sequence Number: 5739759
• Product Code: FPA
• UDI-Device Identifier: 00814371020525
• UDI-Public: (01)00814371020525(17)280228(10)2502046
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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 Model Number: BX-70070
• Device Catalogue Number: BX-70070
• Device Lot Number: 2502046
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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