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

Model Number	9799
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hyperventilation (1910)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint history trend analysis was conducted on this product line and found this is the only account that reported anchorfast barrier not adhering with this lot number.The dhr was reviewed and found to be complete and accurate.Since the et tube the anchorfast device was securing self-extubated, this is considered an fda reportable event.The root cause of the anchorfast barrier reportedly not adhering is not known.
Event or Problem Description
It was reported that anchorfast barrier did not adhere to the skin, was very soft, does not keep the endotracheal tube in place, kept moving around, and bends forward.It was reported that they have been changing the anchorfast 3 times per day on one patient.It was further reported that on one patient, the et tube came out completely and the patient required reintubation.They reported that the patient was being weaned off the ventilator to prepare for extubation however was not yet ready for extubation when this happened.They reported that this patient currently remains intubated.

• Brand Name: ANCHORFAST
• Common Device Name: ORAL ENDOTRACHEAL TUBE FASTENER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville. 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft 24477 9998
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 22335224
• Report Number: 1119193-2025-00021
• Device Sequence Number: 9160463
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766(17)300101(30)12(10)5A192
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9799
• Device Catalogue Number: 9799
• Device Lot Number: 5A192
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown