MAUDE Adverse Event Report: MEDSOURCE LABS LLC CURAPLEX; CURAPLEX SELECT ENDOTRACHEAL TUBE WITH STYLETTE

Model Number	2113-10280
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The cuff was inflated and leaked.

• Brand Name: CURAPLEX
• Common Device Name: CURAPLEX SELECT ENDOTRACHEAL TUBE WITH STYLETTE
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct; chanhassen MN 55317
• MDR Report Key: 22794776
• Report Number: 3003674698-2025-01032
• Device Sequence Number: 8264531
• Product Code: LNZ
• UDI-Device Identifier: 00815277024358
• UDI-Public: 00815277024358
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K080339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 2113-10280
• Device Lot Number: 1012333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown