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

Catalog Number	111782-000065
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during the cuff test, it was found broken that could not be inflated." this was found prior to use during patient inspection.
Event or Problem Description
It was reported "during the cuff test, it was found broken that could not be inflated." this was found prior to use during patient inspection.
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.Device is meeting the visual inspection following manufacturing released standards.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 the cuff, and it was observed that there is 2 small hole on the inflation tube (side arm).The small hole on the cuff prevented the cuff inflating.Based on our standard production method such cut mark would be detectable during the 100% leak test conducted during inspection and will be rejected immediately.Dhr investigation from this batch revealed no abnormalities.The qa team approved the release of total 600 units of the product for this lot to the customer.The actual root cause is unable to determine as from manufacturing site, due to the obvious defect such hole able to be detected at slow bertha.Actual root cause could not be verified as manufacturing related.Corrective actions cannot be established since the sample received does not reveal defect that is caused by manufacturing.Due to visual inspection and inflation and deflation was 100% conducted in manufacturing process and such obvious defect able to be detected and taken out as it will fail all the testing at manufacturing site.From observation and verification on actual sample returned, the cuff is in good condition.However, there were two small holes observed on the inflation side of the side arm that prevented the cuff from inflating.Thus, this defect could not be determined as manufacturing related, and this complaint is not verified." teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: TRACHEAL TUBE, CUFFED, NASAL PREFORMED
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19985899
• Report Number: 8040412-2024-00196
• Device Sequence Number: 4363143
• Product Code: BTR
• UDI-Device Identifier: 04026704325641
• UDI-Public: (01)04026704325641(11)231231(17)281130(10)40E23M5553(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): 07/18/2024

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: 111782-000065
• Device Lot Number: 40E23M5553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2023
• 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