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	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received reports of leakage from bx-70072-f iv administration sets from lot 2502043.The customer provided images confirming a leak at the bonded junction below the drip chamber.No adverse event or injury was reported.The customer confirmed this is the first lot in which they have seen this issue.An rma (rma17100) was issued, and leaking sets are being returned for evaluation.Lot history review showed (b)(4) units were manufactured.There are no previous complaints.Device evaluation is pending receipt of returned samples.A supplemental mdr will be submitted if new, information becomes available.
Event or Problem Description
Intuvie received reports of leaking bx-70072-f iv sets from lot 2502043.The customer provided images confirming leakage at the bonded joint below the drip chamber.The customer stated this is the first lot in which they have experienced this issue.No adverse event or patient injury was reported.

• 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: 23731981
• Report Number: 3006575795-2025-00742
• Device Sequence Number: 10631990
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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 Expiration Date: 03/14/2026
• Device Model Number: BX-70072-F
• Device Catalogue Number: BX-70072-F
• Device Lot Number: 2502043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2025
• 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