MAUDE Adverse Event Report: TELEFLEX MEDICAL ENDOTRACHEAL TUBE HOLDER ASSY; DEVICE, FIXATION, TRACHEAL TUB

Model Number	IPN049309
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Tissue Breakdown (2681); Insufficient Information (4580)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.The device history record of batch number 74k2102045 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: the endotracheal tube holder assy causes pressure ulcers on the patient's lips, palate, and tongue.

• Brand Name: ENDOTRACHEAL TUBE HOLDER ASSY
• Common Device Name: DEVICE, FIXATION, TRACHEAL TUB
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15910552
• Report Number: 3004365956-2022-00098
• Device Sequence Number: 4384117
• Product Code: CBH
• UDI-Device Identifier: 14026704630094
• UDI-Public: 14026704630094
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2022

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: IPN049309
• Device Catalogue Number: 1065
• Device Lot Number: 74K2102045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown