MAUDE Adverse Event Report: COOPERSURGICAL, INC. NEO-FIT; ENDOTRACHEAL TUBE HOLDER

Model Number	42-2540
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the neo-fit ett holder delaminated from its own adhesive backing while on infant, no harm to patient but it was a near miss.No additional information is available.42-2540 neo-fit (b)(4).
Additional Manufacturer Narrative
Device location is scheduled to be returned.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: NEO-FIT
• Common Device Name: ENDOTRACHEAL TUBE HOLDER
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611 1350
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611 1350
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611-1350 ; 4752651582
• MDR Report Key: 24817070
• Report Number: 1216677-2026-00030
• Device Sequence Number: 9630832
• Product Code: JAY
• UDI-Device Identifier: 00888937016659
• UDI-Public: (01)00888937016659(10)336625
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: 42-2540
• Device Catalogue Number: 42-2540
• Device Lot Number: 336625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2023
• 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
• Patient Sex: Unknown