MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN048997
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Mdr report key/report number: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A verification of the reported failure mode was conducted, and 80 samples were taken from another part number from the same family (5-16039 et tube, sher-i-bronch, ls, 39 fr lot # 3009475) at the manufacturing facility.The samples were visually inspected, and issue reported "b locked/obstructed - tracheal tubing" was not observed.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
Complaint from maude database: it was reported "patient was intubated with a double lumen endotracheal tube without difficulty.Placement was verified with fiberoptic scope by thoracic surgeon.While passing fiberoptic scope down tracheal lumen of the tube, a small plastic piece was noted along the bottom half of the inside of endotracheal tube.Suction was applied to the piece of plastic via fiberobtic scope and piece was removed.Plastic piece never entered the patient's airway.No harm was done to patient.Decision was made to extubate and reintubate with a new double lumen tube".Patient condition not reported.

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, LS, 39 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11488371
• Report Number: 3003898360-2021-00247
• Device Sequence Number: 3412941
• Product Code: CBI
• UDI-Device Identifier: 14026704617415
• UDI-Public: 14026704617415
• Combination Product (Y/N): N
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: No Information
• Device Expiration Date: 06/29/2025
• Device Model Number: IPN048997
• Device Catalogue Number: 5-16039
• Device Lot Number: 73F2000547
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1