MAUDE Adverse Event Report: CooperSurgical, Inc. NEO-fit; Endotracheal tube holder

Model Number	42-2540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that homerton university hospital experienced multiple issues with this batch of neofit not adhering properly, causing unplanned extubation.Multiple attempts have been made, but no additional information has been provided.1216677-2026-00136 42-2540 neo-fit (b)(4).
Additional Manufacturer Narrative
G2: foreign: united kingdom device location is unknown.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 -135
• Manufacturer (Section G): CooperSurgical, Inc.; 75 corporate drive; trumbull CT 06611 -135
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611--135 ; +1(475)265-1582
• MDR Report Key: 50840556
• Report Number: 1216677-2026-00136
• Device Sequence Number: 10461364
• Product Code: JAY
• UDI-Device Identifier: 00888937016659
• UDI-Public: (01)00888937016659(10)550035487
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 550035487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/21/2026
• 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
• Patient Sex: Unknown