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

Model Number	9800
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to hollister through an fda medwatch the following: during head turn of a prone patient, the anchorfast clip broke causing endotracheal tube dislodgement.
Additional Manufacturer Narrative
Trend analysis conducted and no adverse trends observed for clip breaking and 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 clip breaking during repositioning cannot be determined.

• Brand Name: ANCHORFAST GUARD ORAL ENDOTRACHEAL TUBE FASTENER
• Common Device Name: ANCHORFAST GUARD
• 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: 24367086
• Report Number: 1119193-2026-00012
• Device Sequence Number: 5381260
• Product Code: CBH
• UDI-Device Identifier: 00610075186518
• UDI-Public: (01)00610075186518(17)300301(30)12(10)5C212
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Literature
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9800
• Device Lot Number: 5C212
• 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: 02/12/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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 Age: 28 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Hispanic