MAUDE Adverse Event Report: HUDSON ET TUBE HOLDER, STANDARD; TRACHEAL TUBE FIXATION DEVICE

Model Number	IPN914324
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
In the process of attempting to unblock the ett holder device, the responding caregiver was unable to do so as the mechanism was broken.The tubing was unable to unblock or release.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Maude report: in the process of attempting to unblock the ett holder device, the responding caregiver was unable to do so as the mechanism was broken.The tubing was unable to unblock or release.

• Brand Name: HUDSON ET TUBE HOLDER, STANDARD
• Common Device Name: TRACHEAL TUBE FIXATION DEVICE
• MDR Report Key: 11616330
• Report Number: 8040412-2021-00101
• Device Sequence Number: 3049771
• Product Code: CBH
• UDI-Device Identifier: 14026704646965
• UDI-Public: 14026704646965
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: No Information
• Device Expiration Date: 03/28/2022
• Device Model Number: IPN914324
• Device Catalogue Number: 81801
• Device Lot Number: 35208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.