MAUDE Adverse Event Report: HOLLISTER, INC ENDOTRACHEAL TUBE ATTACHMENT DEVICE; DEVICE, FIXATION, TRACHEAL TUBE

Model Number	9799
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the small plastic tab which secures the tube broke off and fell into the patient's mouth.Sku unknown, lot # 5g032.The event was described as: registered nurse (rn) reportedly noticed that it was "deep in the mouth" and was "unable to be retrieved".It was reported that the medical doctor used a laryngoscope to "visualize the plastic piece but was unable to remove it with a yankauer and forceps due to secretions, angle, and positioning of the piece".It was reported that "further attempts were made by the medical doctor with bronchoscope via nasal passageway which was said to be not successful in visualizing plastic piece".Ct (computed tomography) scans reportedly did not reveal any radiopaque foreign bodies.
Additional Manufacturer Narrative
The device is not available for evaluation.Lot number provided and records were found to be complete and accurate.Root cause was unable to be determined.This appears to be an isolated event.Hollister will continue to monitor this type of issue in our post-market surveillance system.

• Brand Name: ENDOTRACHEAL TUBE ATTACHMENT DEVICE
• Common Device Name: DEVICE, FIXATION, TRACHEAL TUBE
• Manufacturer (Section D): HOLLISTER, INC; 2000 hollister drive; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER, INC.; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: karen deering ; 2000 hollister drive; libertyville 60048
• MDR Report Key: 23801911
• Report Number: 1119193-2025-00046
• Device Sequence Number: 7686525
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766(17)300701(30)12(10)5G032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: 5G032
• 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: 12/03/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2025
• 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