MAUDE Adverse Event Report: TELEFLEX MEDICAL LARYNGECTOMY TUBE, CUFFED; TUBE, TRACHEOSTOMY (W/WO CONN

Model Number	IPN917177
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: female patient (gra), 50-years-old, hospitalized for a squamous cell carcinoma on left posterior pharyngeal wall.In preoperative setting, a tracheostomy performed with montandon tube.Twice, on 2 different devices from 2 different lots, during insertion, the cuff is pierced.The cuff was pre-tested before use without any issues.Additional information indicates that on removal of the tube a hole was observed.There was no injury and the patient's condition reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported issue: female patient (gra), 50-years-old, hospitalized for a squamous cell carcinoma on left posterior pharyngeal wall.In preoperative setting, a tracheostomy performed with montandon tube.Twice, on 2 different devices from 2 different lots, during insertion, the cuff is pierced.The cuff was pre-tested before use without any issues.Additional information indicates that on removal of the tube a hole was observed.There was no injury and the patient's condition reported as fine.8040412-2023-00151.
Additional Manufacturer Narrative
Qn#(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 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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).The actual sample was returned for investigation.The pressure of the cuff was tested by attempting to inflate it to 25 mbar using a calibrated endotest.It was found that the cuff was unable to be inflated at all.A visual inspection was performed on the cuff and a cut mark was observed.The complaint of leakage was confirmed; however, a root cause for the issue could not be determined.There is a 100% leak test conducted at the manufacturing facility whereby any leakage would be detected prior to release.It is suspected that the failure occurred during the procedure and is user related.
Event or Problem Description
Reported issue: female patient (gra), 50-years-old, hospitalized for a squamous cell carcinoma on left posterior pharyngeal wall.In preoperative setting, a tracheostomy performed with montandon tube.Twice, on 2 different devices from 2 different lots, during insertion, the cuff is pierced.The cuff was pre-tested before use without any issues.Additional information indicates that on removal of the tube a hole was observed.There was no injury and the patient's condition reported as fine.8040412-2023-00151.

• Brand Name: LARYNGECTOMY TUBE, CUFFED
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONN
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• 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 ; 9194332672
• MDR Report Key: 16733342
• Report Number: 8040412-2023-00150
• Device Sequence Number: 15164319
• Product Code: BTO
• UDI-Device Identifier: 04026704012916
• UDI-Public: 04026704012916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2023

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 Expiration Date: 03/28/2024
• Device Model Number: IPN917177
• Device Catalogue Number: 121181-000080
• Device Lot Number: KME22D1143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 11/15/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/19/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2022
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Patient Age: 50 YR
• Patient Sex: Female