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

Model Number	9799
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed for et tube migration.Device history review conducted based on lot number provided and records found to be complete and accurate.Sample not returned so sample evaluation not possible.Root cause of reported et tube migration during a patient turn cannot be determined.
Event or Problem Description
It was reported to hollister through an fda medsun the following: patient turned for incontinent care.Initially turned to pt's right side, when turned onto back (before being turned to left side), another rn noted ett [endotracheal tube] move out.Anchorfast was in place with securement strap on.Respiratory therapist nearby and immediately came to bedside.App [advance practice practitioner] and intensivist called to bedside.Ett removed and new ett inserted by intensivist.Prior to turn ett was assessed and in correct position.

• 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: 24336542
• Report Number: 1119193-2026-00006
• Device Sequence Number: 4876491
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766(17)300901(30)12(10)5I282
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/13/2026

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
• Device Lot Number: 5I282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2025
• 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