MAUDE Adverse Event Report: ZYNO MEDICAL, LLC BX70071P; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	BX70071-P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the administration set tubing leaked immediately once fluids were initiated during infusion.According to nursing staff, no visible defects were observed on the tubing prior to infusion.No adverse event or patient injury was reported.
Additional Manufacturer Narrative
Follow-up communication with the reporting facility was conducted to obtain additional information related to the reported tubing leakage.The manufacturer requested the return of the affected administration sets for evaluation.During follow-up, the customer indicated that the product may have been exposed to cold temperatures during storage or transport, which was noted as a potential contributing factor.A review of manufacturing and lot release documentation for lot 2503016 was performed.The lot consisted of 9,000 units and was manufactured, tested, and released in accordance with applicable quality system requirements.Review of complaint history for this lot identified no previous complaints associated with the same failure mode.Sterilization and production records for the lot were reviewed and found to be acceptable, with no nonconformities noted during manufacturing or sterilization processing.Evaluation of returned product, if received, will be conducted as part of the ongoing investigation to further assess the reported issue.
Additional Manufacturer Narrative
A follow-up received on february 5, 2026, included an image indicating that the leak was originating from the seal below the drip chamber.Based on this information, the component code was updated to reflect the suspected failure location.Samples from the same lot were returned to intuvie on february 26, 2026, and are currently undergoing evaluation.Refer to complaint record (b)(4) for additional details related to this event and the manufacturer¿s evaluation.
Event or Problem Description
A customer reported that the administration set tubing leaked immediately once fluids were initiated during infusion.According to nursing staff, no visible defects were observed on the tubing prior to infusion.No adverse event or patient injury was reported.

• Brand Name: BX70071P
• 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: 24268971
• Report Number: 3006575795-2026-00925
• Device Sequence Number: 16133155
• Product Code: FPA
• UDI-Device Identifier: 00814371020563
• UDI-Public: (01)00814371020563(17)280104(10)2503016
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2026

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: Lay User/Patient
• Device Model Number: BX70071-P
• Device Catalogue Number: BX70071-P
• Device Lot Number: 2503016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 05/13/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/05/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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