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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "prior to use & inspection, found cuff line broken." there was no patient involvement.No patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Udi:(b)(4).The sample was sent to the manufacturer for evaluation.The manufacturer reported: "one piece of actual sample was received for further investigation.Visual inspection was conducted on the received sample.Cuff pressure of the sample was then tested by inflates the cuff to 25 mbar using calibrated endotest.It was observed that the cuff could not inflate.Based on the evaluation sample, hole was observed at inflation tube.Hence, leading to leak inflation tube and unable to inflate the cuff.By checking on pouch itself, no caught in seal defect found along the sealing area pouch.In addition, visual inspection, inflation, and deflation test were performed in manufacturing and such obvious defect able to be detected and taken out as it will fail all the testing at manufacturing site.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.Based on the investigation, the defect mode on cuff line (inflation tube) broken matches with the complainant report.However, in manufa cturing site, there were visual inspection, inflation and deflation test were performed in manufacturing and such obvious defect able to be detected and taken out as it will fail all the testing at manufacturing site." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "prior to use & inspection, found cuff line broken." there was no patient involvement.No patient harm or injury.

• 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: 19017489
• Report Number: 8040412-2024-00089
• Device Sequence Number: 12805102
• Product Code: BTR
• UDI-Device Identifier: 04026704325658
• UDI-Public: 04026704325658
• 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): 03/07/2024

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: 02/28/2026
• Device Catalogue Number: 111782-000070
• Device Lot Number: KME21C2560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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