MAUDE Adverse Event Report: HOLLISTER INCOPORATED ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER; ANCHORFAST, PRODUCT CODE: CBH

Model Number	9799
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dhr review not possible because lot number not provided.It was not known if there was any device adhesion issues.The root cause of the reported extubations are not known.Only the di information of the udi is know due to lack of lot number.
Event or Problem Description
It was reported that the family removed wrist restraints and patient pulled tube out.

• Brand Name: ANCHORFAST ORAL ENDOTRACHEAL TUBE FASTENER
• Common Device Name: ANCHORFAST, PRODUCT CODE: CBH
• Manufacturer (Section D): HOLLISTER INCOPORATED; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCOPORATED; 2000 hollister drive; libertyville IL 60048
• Manufacturer Contact: andrea clark ; 2000 hollister drive; libertyville, IL 60048 ; 4632667911
• MDR Report Key: 25599735
• Report Number: 1119193-2026-00046
• Device Sequence Number: 18592473
• Product Code: CBH
• UDI-Device Identifier: 00610075129386
• UDI-Public: (01)00610075129386
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 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: Not provided
• Initial Report FDA Received Date: 06/23/2026
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown