MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK; TRACHEAL TUBE FIXATION DEVICE

Model Number	IPN914325
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported via the medwatch form that the endotracheal tube (ett) holder was in place, rt found the ett tube may have been allowed to migrate/dislodge.There are reports that this tube holder does not work as designed to secure the ett tubes and prevent from dislodging." the reported defect was detected during use on patient.The patient condition is reported as "deceased": (b)(6) 2022.Additional information was received, and it was confirmed that the teleflex et holder had been in place on (b)(6) 2022 prior to the passing of the patient and was left in place by the rt's present post code, and did not directly contribute to the patient's death.
Additional Manufacturer Narrative
(b)(4).Mdr report key (b)(4); mdr text key (b)(4).Complaint verification testing could not be performed as it was reported that no sample is available 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." the manufacturing site also reports, "according to the ifu as in picture 1, the user are advised to aware of the precautions and follow the ifu accordingly to avoid potential injury to the patients." 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
It was reported via the medwatch form that the endotracheal tube(ett) holder was in place, rt found the ett tube may have been allowed to migrate/dislodge.There are reports that this tube holder does not work as designed to secure the ett tubes and prevent from dislodging." the reported defect was detected during use on patient.The patient condition is reported as "deceased"- (b)(6) 2022.Additional information was received, and it was confirmed that the teleflex et holder had been in place on (b)(6) 2022 prior to the passing of the patient and was left in place by the rt's present post code, and did not directly contribute to the patient's death.

• Brand Name: HUDSON ET TUBE HOLDER, STANDARD, W/BITE BLOCK
• Common Device Name: TRACHEAL TUBE FIXATION DEVICE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14356479
• Report Number: 8040412-2022-00128
• Device Sequence Number: 4921554
• Product Code: CBH
• UDI-Device Identifier: 14026704646972
• UDI-Public: 14026704646972
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: IPN914325
• Device Catalogue Number: 81802
• Device Lot Number: KMZ21E0161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/21/2022
• 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.
• Outcome Attributed to Adverse Event: Death; Life Threatening; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male