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

Model Number	9799
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Cough (4457)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an rn was alerted by the vital signs monitor to a patient's spo2 decreasing.It was reported that upon entry to room, they witnessed patient in a coughing fit, and the endotracheal tube actively tidaling in depth with forceful exhalations.It was reported that the rn took manual control of the et tube and noted that the tube had migrated to approximately 20cm at the teeth from 24cm.It was reported that the registered respiratory therapist attended, and the tube was re-inserted to original depth.It was reported that during the rrt assessment, the hollister anchorfast endotracheal tube securement device was noted to have loosened spontaneously.It was also reported that all clamps on anchorfast device remain locked and that no tears or damage noted.It was reported that the patient's spo2 decreased below 80% for approximately 60 seconds due to equipment failure / spontaneous endotracheal tube mis-positioning & massive air leak.
Additional Manufacturer Narrative
The anchorfast device was not saved; therefore, a device evaluation could not take place.A lot number was not provided so a dhr review could not take place.A complaint history trend analysis was conducted for similar complaints and no adverse trends for unintended extubations were observed.A root cause fo the unintended extubation could not be determined.Hollister will continue to monitor this reported issue.Since the lot number was not known, only the di portion of the udi is known.

• 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: 23014736
• Report Number: 1119193-2025-00037
• Device Sequence Number: 15869446
• Product Code: CBH
• UDI-Device Identifier: 00610075129386
• UDI-Public: (01)00610075129386
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

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: 08/27/2025
• Initial Report FDA Received Date: 09/10/2025
• 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 Sex: Unknown