MAUDE Adverse Event Report: Zyno Medical, LLC BX-70071-P; Set, Administration, Intravascular

Model Number	BX-70071-P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: BX-70071-P
• 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 ; +1(508)650-2007
• MDR Report Key: 50827533
• Report Number: 3006575795-2026-01360
• Device Sequence Number: 13436024
• Product Code: FPA
• UDI-Device Identifier: 00814371020563
• UDI-Public: (01)00814371020563(17)280805(10)2507063
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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 Model Number: BX-70071-P
• Device Catalogue Number: BX-70071-P
• Device Lot Number: 2507063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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