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

Catalog Number	112082075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "the patient was intubated, the doctor inflated the balloon and realized that the balloon was deflating and decided to remove the tube and place another one." per the customer, it is unknown if there was any patient harm, desaturation or injury or the patient's current status.If additional information is received, the complaint file will be updated.
Event or Problem Description
It was reported that "the patient was intubated, the doctor inflated the balloon and realized that the balloon was deflating and decided to remove the tube and place another one." per the customer, it is unknown if there was any patient harm, desaturation or injury or the patient's current status.If additional information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable root cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: SAFETY CLR MURPHY CUF ET
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17586326
• Report Number: 8040412-2023-00321
• Device Sequence Number: 3627058
• Product Code: BTR
• UDI-Device Identifier: 14026704341433
• UDI-Public: 14026704341433
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

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 Catalogue Number: 112082075
• Device Lot Number: KME22C2437
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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
• Patient Sex: Unknown