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

Model Number	9799
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	07/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The specific mechanism of failure relating to the anchorfast device resulting in extubation was not identified so a trend analysis could not be conducted.Additionally, a review of the device history record (dhr) was not feasible, as the lot number was not provided.The product sample was not retained for return so a sample evaluation could not be conducted.Consequently, the root cause of the reported issue could not be determined.Only the device identifier (di) portion of the unique device identifier (udi) was available, as the lot number was not included in the report.
Event or Problem Description
It was reported that a patient who had the hollister anchorfast endotracheal tube fastener in place self-extubated.It was further reported that the staff were weaning the patient off of sedation in preparation for a planned extubation when this event happened.It was reported that the patient was either under minimal or no sedation at the time and the patient had mitts on their hands to prevent them from grabbing at the tube.It was also reported that staff had assessed the patient shortly prior to the extubation and observed that the anchorfast device was securely in place.Additionally, it was reported that the patient was able to remain extubated on an aerosol mask post extubation.

• Brand Name: ANCHORFAST
• Common Device Name: ORAL ENDOTRACHEAL TUBE FASTENER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048 ; 8479321271
• MDR Report Key: 22699308
• Report Number: 1119193-2025-00028
• Device Sequence Number: 12981385
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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
• Device Catalogue Number: 9799
• Device Lot Number: UNKNOWN
• 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: 07/31/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown