MAUDE Adverse Event Report: TELEFLEX MEDICAL LASERTUBUS 5MM; TUBE, TRACHEAL (W/WO CONNECTO

Model Number	IPN040898
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during use the proximal portion of the tube folded, almost at right angles, in the mount of the patient, with both the cuffs between the vocal cords, making impossible ventilation flow." additional information received stated that "no desaturation or clinical complication for the patient.They solved the issue using another laser tube".Patient condition reported as "fine".
Event or Problem Description
It was reported that: "during use the proximal portion of the tube folded, almost at right angles, in the mount of the patient, with both the cuffs between the vocal cords, making impossible ventilation flow." additional information received stated that "no desaturation or clinical complication for the patient.They solved the issue using another laser tube".Patient condition reported as "fine".
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.

• Brand Name: LASERTUBUS 5MM
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• Manufacturer (Section G): TELEFLEX MEDICAL; willy-rusch-str. 4 - 10; 71394 kernen 71394 ; GM 71394
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15693263
• Report Number: 9610520-2022-00006
• Device Sequence Number: 7384669
• Product Code: BTR
• UDI-Device Identifier: 04026704002658
• UDI-Public: 04026704002658
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K935842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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 Expiration Date: 01/31/2024
• Device Model Number: IPN040898
• Device Catalogue Number: 102004-000050
• Device Lot Number: 22061
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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