MAUDE Adverse Event Report: TELEFLEX MEDICAL SHERIDAN ET TUBE, SHER-I-BRONCH, LS, 37 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Catalog Number	5-16037
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The report states, "started case with an lma size 5.Did a bronchoscopy, and then swapped the lma out with a 37 french double lumen tube using the glidescope.They were having some difficulty passing the tube and noticed the tube getting too soft when it was in the mouth for a short period of time.Once the stylet was pulled out/removed they noticed kinking.They removed this tube and successfully passed new one".No patient harm or injury other than a sore throat.The patient status is reported as "recovered uneventfully".
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi #.Additionally added the brand name of the device.Udi related data quality updates only.
Event or Problem Description
The report states, "started case with an lma size 5.Did a bronchoscopy, and then swapped the lma out with a 37 french double lumen tube using the glidescope.They were having some difficulty passing the tube and noticed the tube getting too soft when it was in the mouth for a short period of time.Once the stylet was pulled out/removed they noticed kinking.They removed this tube and successfully passed new one".No patient harm or injury other than a sore throat.The patient status is reported as "recovered uneventfully".

• Brand Name: SHERIDAN ET TUBE, SHER-I-BRONCH, LS, 37 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18182983
• Report Number: 3003898360-2023-01504
• Device Sequence Number: 15352833
• Product Code: CBI
• UDI-Device Identifier: 04026704397617
• UDI-Public: (01)04026704397617(11)230112(17)280111(10)73A2300130(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Catalogue Number: 5-16037
• Device Lot Number: 73A2300130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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
• Patient Sex: Male