MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, SHER-I-BRONCH, LS, 35 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN048995
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).The complaint verification testing could not be performed as no sample was returned for analysis.The manufacturing site reports a verification of failure mode reported in the current manufacturing process was conducted as follows: 13 samples were taken from the current production; the samples were functional inspected , and issue reported blocked/obstructed-tracheal tubing was not observed in the current manufacturing process.A device history record review was also 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.
Event or Problem Description
Reported issue: the tube was blocked when using it on the patient.A new tube was used and there was no impact on the patient.

• Brand Name: ET TUBE, SHER-I-BRONCH, LS, 35 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16492251
• Report Number: 3003898360-2023-00273
• Device Sequence Number: 6296934
• Product Code: CBI
• UDI-Device Identifier: 14026704617392
• UDI-Public: 14026704617392
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180253
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/07/2023

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: 03/18/2024
• Device Model Number: IPN048995
• Device Catalogue Number: 5-16035
• Device Lot Number: 73C1900331
• 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: 02/07/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown