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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The anchorfast device was not saved; therefore, a device evaluation could not take place.A complaint history trend analysis was conducted for similar complaints and no adverse trends were observed for et tube clamp sliding off the end of the track.Although the specific lot number for this reported event was not known, a device history records (dhr) review was conducted on two possible lot numbers and the records were found to be complete and accurate.Hollister will continue to monitor this reported issue.Since the exact lot number was not known, only the di portion of the udi is known.
Event or Problem Description
It was reported that an orally intubated patient sat up in bed independently.It was further reported that this caused a certain amount of tension on the endotracheal tube and consequently also on the anchorfast device.In addition, it was reported that the clamp could not be locked properly in place after being moved several times and that during the time the tension was applied, the anchorfast clamp detached from the end of the anchorfast track and the et tube was no longer fixed to the patient.It was reported that the et tube slipped out of position and needed to be repositioned.It was additionally reported that there was no adverse effect to the patient.

• 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: 21228451
• Report Number: 1119193-2025-00001
• Device Sequence Number: 8292819
• Product Code: CBH
• UDI-Device Identifier: 00610075129386
• UDI-Public: (01)00610075129386
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/24/2025
• 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