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

Model Number	9787
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the upper lip foam spacer from an anchorfast slimfit oral endotracheal tube fastener separated from the plastic anchorfast slimfit track on a patient who had the device in place for 7 hours.It was reported that this separation was not witnessed, and the piece was found hanging on the outside of the patient's mouth.It was further reported that there was no adverse event associated with this report.
Additional Manufacturer Narrative
Samples from the same lot of anchorfast device returned by customer and evaluated.This is being investigated as part of a manufacturing capa.The lot number was provided and the dhr review found the records to be complete and accurate.A complaint history trend analysis was conducted on this product line and found this is the only account that reported lip spacer separation with this lot number.

• Brand Name: ANCHORFAST SLIMFIT
• 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: 21917495
• Report Number: 1119193-2025-00010
• Device Sequence Number: 9031734
• Product Code: CBH
• UDI-Device Identifier: 00610075095834
• UDI-Public: (01)00610075095834(17)300201(30)12(10)5B122
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9787
• Device Catalogue Number: 9787
• Device Lot Number: 5B122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown