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

Model Number	9799
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The anchorfast device was not saved; therefore, a device evaluation could not take place.The lot number was not provided so a dhr review could not be conducted.A complaint history trend analysis was conducted for similar complaints and no adverse trends were observed for et tube slipping through the et tube wrap hollister will continue to monitor this reported issue.Since the exact lot number was not known, only the di portion of the udi is known.
Event or Problem Description
It was reported that a patient who was using the hollister anchorfast endotracheal tube holder, and was awake and appropriate, experienced an et tube slippage of 3 cm through the et tube wrap while the skin barrier pads remained secure to the patient's face.It was further reported that this did not lead to an extubation, but the facility opted to remove the anchorfast device and replace it with tape to secure the et tube.

• 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., IL 60048 ; 8479321271
• MDR Report Key: 21151592
• Report Number: 1119193-2025-00003
• Device Sequence Number: 9134121
• Product Code: CBH
• UDI-Device Identifier: 00610075129386
• UDI-Public: (01)00610075129386
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 01/10/2025
• Initial Report FDA Received Date: 01/14/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 71 KG