MAUDE Adverse Event Report: HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK; TRACHEAL TUBE FIXATION DEVICE

Model Number	IPN914325
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "we had a patient in sicu bite through the block and his ett requiring emergent reintubation".It was reported that "patients current condition is extubated and discharged from facility".New device was used with no report of patient injury or harm.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The manufacturing site reports that "power choice had carried out the static test (sampling check) as per the astm 2726 for each lot that produced.There is no lots rejected in-house due to the same issue as reported by complainant." 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
It was reported "we had a patient in sicu bite through the block and his ett requiring emergent reintubation".It was reported that "patients current condition is extubated and discharged from facility".New device was used with no report of patient injury or harm.

• Brand Name: HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK
• Common Device Name: TRACHEAL TUBE FIXATION DEVICE
• MDR Report Key: 11747021
• Report Number: 8040412-2021-00119
• Device Sequence Number: 14509633
• Product Code: CBH
• UDI-Device Identifier: 14026704646972
• UDI-Public: 14026704646972
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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 Model Number: IPN914325
• Device Catalogue Number: 81802
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/01/2021
• 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: ET TUBE; ET TUBE