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

Model 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	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and 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
It was reported that the patient experienced a self-extubation by coughing out their endotracheal tube while the tube was being secured by the hollister anchorfast endotracheal tube holder.It was reported that limited information was available, but the devices are routinely replaced every 48 hours and are shuttled every 4 hours.It was additionally reported that the lot number was not known, the device was not returned or saved for evaluation, no device defect was reported, and the patient's condition following the event was not known.

• Brand Name: ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER
• Common Device Name: ANCHORFAST
• 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: linda wisowaty ; 2000 hollister drive; libertyville, IL 60048-3781
• MDR Report Key: 24444631
• Report Number: 1119193-2026-00014
• Device Sequence Number: 21409385
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2026

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 Model Number: 9799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 02/25/2026
• 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