MAUDE Adverse Event Report: ZYNO MEDICAL, LLC BX-70072-F; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	BX-70072-F
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
For lot 2502043, the customer reported two additional leaking administration sets on (b)(6) 2025.The customer provided a video documenting the issue, which showed fluid leaking from below the drip chamber.No patient involvement or adverse event was reported at the time of this complaint.
Additional Manufacturer Narrative
A review of complaint history for lot 2502043 was conducted.Two complaint records were identified from the same customer, including this complaint, with a total reported quantity of five affected administration sets.The end user provided a video documenting the reported issue.Review of the video confirmed visible fluid leakage originating below the drip chamber at the bonded connection between the drip chamber and the tubing.Manufacturing and release documentation for lot 2502043 (bx-70072-f) was reviewed, including the certificate of conformance and certificate of sterilization.The lot consisted of (b)(4) units, was manufactured on march 15, 2025, sterilized using ethylene oxide under load number (b)(4), and released to finished goods after meeting applicable manufacturing, inspection, and sterilization requirements.This failure mode is being evaluated under capa zm2023-20, ¿zyno iv set ¿ iv set issues.¿ additionally, an existing supplier corrective action request (scar 2025-007) has been issued to the contract manufacturer, xingda, related to administration set leakage.Intuvie received two unused cases of the affected administration sets from the customer on december 22, 2025.Testing of the returned sets is currently ongoing.A follow-up mdr will be submitted upon completion of the evaluation to report the test results and investigation conclusions.Refer to (b)(4).

• Brand Name: BX-70072-F
• 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: 23980310
• Report Number: 3006575795-2026-00832
• Device Sequence Number: 16104297
• Product Code: FPA
• UDI-Device Identifier: 00814371020587
• UDI-Public: (01)00814371020587(17)260314(10)2502043
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/06/2026

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 Expiration Date: 03/19/2026
• Device Model Number: BX-70072-F
• Device Catalogue Number: BX-70072-F
• Device Lot Number: 2502043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown