MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACHEAL TUBE, CUFFED, NASAL PREFORMED; BE, TRACHEAL (W/WO CONNECTOR

Catalog Number	111782-000070
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "prior to use & test the cuff could not inflate (cuff leakage)".There was no paitent involvement.No patient harm or injury.
Event or Problem Description
It was reported "prior to use and test the cuff could not inflate (cuff leakage)".There was no patient involvement.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).The sample was returned to the manufacturer for evaluation.The manufacturer reported: "one actual sample was received in an open pouch for further evaluation.Visual inspection was conducted on the received sample and no abnormalities was observed.The cuff pressure of the actual returned sample was inflated to 25 mbar by using calibrated endotest.However, the cuff was unable to maintain its pressure at 25 mbar.Further inspection carried out on cuff, observed with a cut mark on the inflation tube of the side arm.The cut mark on the side arm prevents the cuff from inflating.Based on our standard production method (spm) such cut mark would be detectable during 100% leak test conducted during inspection and will be rejected immediately.Based on the investigation, the defect mode on cuff could not inflate matches with the complainant report.There was cut mark observed on the side arm of actual sample.However, a 100% visual inspection of inflation and deflation is conducted during the manufacturing process.Such an obvious defect would be detected and removed, as it would fail all testing at the manufacturing site.Thus, this defect could not be determined as manufacturing related.The returned complaint device did not meet manufacturing release specifications as a cut mark was observed on side arm.The complaint was not confirmed, and the root cause was not determined." teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: TRACHEAL TUBE, CUFFED, NASAL PREFORMED
• Common Device Name: BE, 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19790544
• Report Number: 8040412-2024-00168
• Device Sequence Number: 15232326
• Product Code: BTR
• UDI-Device Identifier: 04026704325658
• UDI-Public: (01)04026704325658(11)231126(17)281031(10)40E23L3710(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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
• Device Catalogue Number: 111782-000070
• Device Lot Number: 40E23L3710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown