MAUDE Adverse Event Report: SALTER LABS Parker Flex-Tip; Tube, Tracheal (W/Wo Connector)

Model Number	H-PFHV-80
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Stacking Breaths (1593); Pneumothorax (2012); Swelling/ Edema (4577)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient in ep "[electrophysiology]" for watchman procedure on "[redacted]".Per documentation no complications during intubation or recovery.Anes induction at 1258, anes end at 1359.Patient arrived to ccl "[cardiac cath lab]" recovery at 1400.Recovery was uneventful and patient was about to be discharged to home (in a wheelchair) when patient then complained of sob "[shortness of breath]" and a lump in the throat and developed facial swelling.Cxr showed: 1.Small right apical pneumothorax.2.Pneumomediastinum and soft tissue gas throughout the lower neck and chest wall.3.Patchy opacities throughout both lungs, most prominent at the right lung base, compatible with multifocal pneumonia.4.Loop recorder overlies the left heart.Patient resp status continued to decline and decision was made to intubate patient.Patient transferred to icu where bedside bronch was completed and a 1cm tracheal tear was found in the main carina.Patient was taken operating room for repair.

• Brand Name: Parker Flex-Tip
• Common Device Name: Tube, Tracheal (W/Wo Connector)
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• MDR Report Key: 50818324
• Report Number: 50818324
• Device Sequence Number: 18686320
• Product Code: BTR
• UDI-Device Identifier: 10749065011800
• UDI-Public: (01)10749065011800
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/09/2026
• Report Date (Section F): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: H-PFHV-80
• Device Catalogue Number: H-PFHV-80
• Device Lot Number: 2511HV3978M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown
• Patient Weight: 163 LB
• Date Report Sent to FDA: 09/09/2026