MAUDE Adverse Event Report: Hollister Incorporated AnchorFast Guard; Oral Endotracheal Tube Fastener

Model Number	9800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while a patient was using a hollister anchorfast guard oral endotracheal tube fastener, the clip thumbtab broke during an endotracheal tube (ett) adjustment.It was further reported that the broken clip migrated into the patient's airway, requiring extensive investigations to determine its location.It was additional reported that the clip was subsequently identified in the left lower lobe bronchus and was retrieved via bronchoscopy on (b)(6) 2026.No residual patient harm was reported following retrieval of the device.
Additional Manufacturer Narrative
A device history record (dhr) record review were completed and no adverse trends identified.All records reviewed were found to be complete and accurate.Based on the available information the root cause could not be determined.

• Brand Name: AnchorFast Guard
• Common Device Name: Oral Endotracheal Tube Fastener
• Manufacturer (Section D): Hollister Incorporated; 2000 hollister drive; libertyville IL 60048 -378
• Manufacturer (Section G): Hollister Incoporated; 366 draft avenue; stuarts draft VA 24477 -999
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; +1(463)266-7911
• MDR Report Key: 50175659
• Report Number: 1119193-2026-00050
• Device Sequence Number: 8263210
• Product Code: CBH
• UDI-Device Identifier: 00610075095780
• UDI-Public: (01)00610075095780(17)310201(30)12(10)6B202
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 9800
• Device Lot Number: 6B202
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2026
• 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