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

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	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of complaint history was conducted for lot number: 2502048, and no other complaints associated with leakage below the drip chamber were identified for this lot.A review of the certificate of conformance documentation confirmed that the lot met all applicable manufacturing and release specifications, with no failures noted during production testing.The customer reported that the affected tubing sets were discarded and will not be returned to intuvie for evaluation.Therefore, the manufacturer was unable to perform a direct examination of the reported product.A corrective and preventive action (capa) was initiated to further evaluate the reported failure.Refer to (b)(4).
Event or Problem Description
It was reported to intuvie that three iv tubing sets (item: bx-70070) from lot number: 2502048 (expiration date: 02/28/2028) leaked from an area below the drip chamber immediately upon removal from the packaging.The three tubing sets were from the same box.No patient injury or adverse event was reported.

• Brand Name: ZYNO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR INTRAVASCULAR ADMINISTRATION SET
• 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: 24404848
• Report Number: 3006575795-2026-00966
• Device Sequence Number: 12829418
• Product Code: FPA
• UDI-Device Identifier: 00814371020525
• UDI-Public: (01)00814371020525(17)280228(10)2502048
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: BX-70070
• Device Catalogue Number: BX-70070
• Device Lot Number: 2502048
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/20/2026
• 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