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	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: foreign: united kingdom.Device location is at the facility of use.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the nursing staff noticed that the velcro holding the tube in the neofit was dislodged, not sticking and dysfunctional, so the tube may come loose or move out of place.Immediately bleeped registar on duty, she came in less than 1 minute and changed neofit to a new one and secured properly at 7 cm at lips, vital signs taken and recorded.No patient harm reported.1216677-2025-00049 (b)(4).
Additional Manufacturer Narrative
Updated: b4, d4, g3, g6, h2, h3, h4, h6, h11.Distribution history: the complaint product was manufactured at csi in 10/04/2024 and was sold on 1/16/2025.Manufacturing record review: dhr was reviewed and no non-conformities, related to the complaint condition, were noted.Incoming inspection review: incoming inspection record review not applicable to this product.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history did not show similar reported complaint conditions for the velcro dislodging.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: root cause not applicable as the complaint condition was not confirmed.Coopersurgical will continue to monitor this complaint condition for trends.
Event or Problem Description
No additional information.

• 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: 23452960
• Report Number: 1216677-2025-00049
• Device Sequence Number: 8961169
• Product Code: JAY
• UDI-Device Identifier: 00888937016659
• UDI-Public: (01)00888937016659(10)550008912(11)241004(17)271004
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 42-2540
• Device Catalogue Number: 42-2540
• Device Lot Number: 550008912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2024
• 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
• Patient Sex: Unknown