MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO RESOLVE® THORACOSTOMY TRAY; CATHETER AND TIP, SUCTION

Catalog Number	RTT14038MB/B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not been returned for evaluation.The device could not be visually investigated.The complaint is not confirmed.The root cause could not be determined.The device history record was reviewed and no exception documents were identified.A search of the complaint database was performed and no similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that during a pneumothorax drainage procedure, the valve was allowing air into the patient as well.No additional intervention was deemed necessary.No additional patient consequence to report.

• Brand Name: RESOLVE® THORACOSTOMY TRAY
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 19762209
• Report Number: 3011642792-2024-00041
• Device Sequence Number: 18271299
• Product Code: JOL
• UDI-Device Identifier: 00884450634905
• UDI-Public: 00884450634905
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: RTT14038MB/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown