MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH SAFETY CLR MURPHY CUF ET TUBE; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	112082065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by clinical staff at te hospital that: "patient presented bradypnea and apnea, with bradycardia and subsequent cardi orespiratory arrest due to hypoxia, requiring support with ventilation and cardiopulmonary resuscitation, intubated at the first attempt, but due to air leakage was changed to a 6.5 cannula with fixed balloon in 16".Additional infomration reported by the clinical staff: "death (b)(6) 2023.Cardiorespiratory arrest unrelated to the device incident.The issue was resolved changing the cannula with another cannula of the same caliber and brand.The air leak was after de arrest.The air leak, didn't delay the health care.The patient didn't suffer hypoxia when the cannula was changed.".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported by clinical staff at te hospital that: "patient presented bradypnea and apnea, with bradycardia and subsequent cardi orespiratory arrest due to hypoxia, requiring support with ventilation and cardiopulmonary resuscitation, intubated at the first attempt, but due to air leakage was changed to a 6.5 cannula with fixed balloon in 16".Additional infomration reported by the clinical staff: "death (b)(6) 2023.Cardiorespiratory arrest unrelated to the device incident.The issue was resolved changing the cannula with another cannula of the same caliber and brand.The air leak was after de arrest.The air leak, didn't delay the health care.The patient didn't suffer hypoxia when the cannula was changed.".
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.

• Brand Name: RUSCH SAFETY CLR MURPHY CUF ET TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• 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
• MDR Report Key: 20107521
• Report Number: 8040412-2024-00205
• Device Sequence Number: 20951059
• Product Code: BTR
• UDI-Device Identifier: 14026704341419
• UDI-Public: (01)14026704341419(11)220813(17)240728(10)19HT61(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K961837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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: Health Professional
• Device Expiration Date: 07/28/2024
• Device Catalogue Number: 112082065
• Device Lot Number: 19HT61
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown