MAUDE Adverse Event Report: ZYNO MEDICAL, LLC B2-70072; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	B2-70072
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer reviewed the photographs provided by the end user, which confirmed the reported tubing separation from the male luer lock adaptor.The affected administration set was requested for return for evaluation; however, despite multiple follow-up attempts to obtain the purchase source and coordinate return of the sample, no further response was received.Consequently, the affected administration set was not returned and a physical evaluation could not be performed.Complaint history and manufacturing records for the reported lot were reviewed and identified no previous complaints, abnormalities, or nonconformances related to the reported failure.Although the device problem was confirmed based on the photographs provided, the specific root cause could not be determined because the affected administration set was unavailable for evaluation.Refer to (b)(4).
Event or Problem Description
The reporter alleged that an iv administration set experienced tubing separation from the male luer lock adaptor prior to patient use.No patient involvement or adverse event was reported.

• Brand Name: B2-70072
• 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: 25692802
• Report Number: 3006575795-2026-01271
• Device Sequence Number: 21195396
• Product Code: FPA
• UDI-Device Identifier: 10814371020195
• UDI-Public: (01)10814371020195(17)280820(10)25085690
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/02/2026

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: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 25085690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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