MAUDE Adverse Event Report: Zyno Medical, LLC Zyno; Set, Administration, Intravascular

Model Number	BX-70071-DF
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction

• Brand Name: Zyno
• 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: 50716267
• Report Number: 3006575795-2026-01350
• Device Sequence Number: 21506875
• Product Code: FPA
• UDI-Device Identifier: 00814371020549
• UDI-Public: (01)00814371020549(17)260411(10)2503046
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 04/11/2026
• Device Model Number: BX-70071-DF
• Device Catalogue Number: BX-70071-DF
• Device Lot Number: 2503046
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2025
• 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