MAUDE Adverse Event Report: ZYNO MEDICAL, LLC BX-70071-D; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	BX-70071-D
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to intuvie that a malfunction occurred with a batch of tubing during the infusion of medication to a patient.This happened in the middle of the infusion.Attached images were provided for reference.As a precaution, all tubing from this lot number was removed from the reporter¿s current inventory.No patient harm was reported.
Additional Manufacturer Narrative
A review of complaint history identified one previous complaint associated with leaking tubing for lot number 2506032.A review of the certificate of conformance confirmed that (b)(4) units were manufactured within this lot.A supplier corrective action request (scar) was opened to investigate the reported issue and remains under investigation.Similar leaking tubing events are also being evaluated under an active capa investigation.Evaluation of the image provided by the end user confirmed a tubing malfunction.The affected administration set will not be returned for evaluation; therefore, the probable cause remains unknown.Refer to com#: (b)(4).

• Brand Name: BX-70071-D
• 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: 25173007
• Report Number: 3006575795-2026-01172
• Device Sequence Number: 10473951
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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-D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 2506032
• 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: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown