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

Model Number	9799
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on rn's final assessment prior to leaving patient alone for ct, patient who had an anchorfast oral endotracheal tube fastener in place was noted to have a new endotracheal tube cuff leak.It was reported that the rn repositioned the patient's head in attempt to resolve leak with no effect, then assessed the et tube which was found to have migrated significantly.It was reported that the final 19cm marker of 6.0 tube was noted to be protruding many cm's past pt's teeth.It was reported that the rn took manual control of et tube, assuming the airway was compromised.It was reported that the rrt approached the bedside to assess, and advanced the et tube to 25cm, and stated that the airway was currently safe but required urgent assessment.It was reported that there was a normal etco2 waveform noted on assessment, and the patient's vital signs with spo2 was higher than 92% throughout.It was reported that the intensivist arrived and requested bronchoscopy equipment and that patient not be moved until determination of safety was made.It was reported that the et tube determined to remain at inadequate depth and the tube was advanced under supervision of icu intensivist to appropriate depth and secured.It was reported that on further assessment later that day, the combination of a 6.0 endotracheal tube and the anchorfast device tube fastener appears to present a risk of patient harm.It was further reported that in this specific situation, when soiled / wet / contaminated with secretions, the endotracheal tube fastener is not securely holding the endotracheal tube in place.It was reported that additional slippage and need for the ett to be re-advanced by 2-3cm was noted during a subsequent assessment.
Additional Manufacturer Narrative
A complaint history trend analysis was conducted on this product line and found that there is no adverse trend for tube migration.The dhr could not be reviewed because the lot number was not known.Since the et tube migrated and needed medical intervention to remedy, this is considered an fda reportable event.Only the di of the udi information is known for this device since the lot number was not provided.

• 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: 22381937
• Report Number: 1119193-2025-00022
• Device Sequence Number: 21191250
• Product Code: CBH
• UDI-Device Identifier: 00610075095766
• UDI-Public: (01)00610075095766
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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
• 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: 06/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIZE 6.0 ENDOTRACHEAL TUBE (MEDTRONIC MF#18860)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown