MAUDE Adverse Event Report: HOLLISTER INCORPORATED ANCHORFAST; ORAL ENDOTRACHEAL TUBE FASTENER

Catalog Number	9799
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and excluding this account, no adverse trends observed for et tube self extubation.Device history records review could not be conducted because the lot number was not provided.Sample not returned so sample evaluation not possible.Root cause of reported et tube self-extubation could not be determined.Only the di portion of the udi information is known due to lack of lot number information.
Event or Problem Description
This report is 4 out of 17 reports.It was reported that this facility observed an increase in unplanned endotracheal tube extubations while the anchorfast endotracheal tube fastener was in use.It was reported that the facility did not observe any device malfunction and they are not sure why the unplanned extubations happened.It was further reported that there were 17 unplanned extubations that occurred between (b)(6) 2025 and (b)(6) 2026.It was reported through chart reviews that the patient's level of sedation ranged from mild to sedated, the anchorfast neck straps were in use, unable to determine how the ventilator circuits were supported, only one incident reported frequent device changes due to clammy skin, but otherwise, their practice is to change the anchorfast device every 48 hours and as needed, and that 2 of the 17 patients were being turned at the time of the unplanned extubation.Hollister is working with the account to provide training and inservicing as needed.

• Brand Name: ANCHORFAST
• Common Device Name: ORAL ENDOTRACHEAL TUBE FASTENER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 3781
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: rebeca thomas ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24766042
• Report Number: 1119193-2026-00021
• Device Sequence Number: 15769904
• Product Code: CBH
• UDI-Device Identifier: 00610075129386
• UDI-Public: (01)00610075129386
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/02/2026
• 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