MAUDE Adverse Event Report: NINGBO HSCC MEDICAL TECHNOLOGY CO. LTD. DYNAREX CORPORATION; 34513 PRESSURE LINE ADAPTER

Model Number	34513
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
N/a.
Event or Problem Description
First event 19-dec-2025 in the initial incident, the patient was on a tracheostomy collar and had been placed on a new airway care setup, which included the pressure line adapter.After being placed on this setup, he patients's oxygen saturation levels declined.Although the patient is normally off the ventilator, the desaturation required placement on a ventilator for approximately twelve hours.Second event 17-feb-2026 a second occurence was identified this week, the same patient was involved.A respiratory therapist noted back pressure on the humidifier, and the water bottle was expanding.This prompted further investigation, which revealed an occluded adaptor.The report issue involves the elbow of the adaptor.At this location, plastic material was found fully occluding the turn within the adaptor.Note: dynarex was not contacted about the first event and was not aware of it until the second event was reported to our attention.Incident location: (b)(6).Contact: (b)(6).

• Brand Name: DYNAREX CORPORATION
• Common Device Name: 34513 PRESSURE LINE ADAPTER
• Manufacturer (Section D): NINGBO HSCC MEDICAL TECHNOLOGY CO. LTD.; 56 luoming south road,; guanhaiwei town, cixi ningbo zhejiang cn 31531 6; CH 315316
• MDR Report Key: 25360209
• Report Number: 2431014-2026-00001
• Device Sequence Number: 10650464
• Product Code: BYX
• UDI-Device Identifier: 00840117340305
• UDI-Public: 00840117340305
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026
• Report Date (Section F): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 34513
• Device Catalogue Number: 34513
• Device Lot Number: 51176
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2026
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 190 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 03/17/2026