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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "presence of a fragment of plastic in the intubation tube whereas the patient was already intubated.This was monitored with a fibroscopy.The device was removed and replaced.There was no consequence for the patient.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Part number reported is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 80 samples were taken from the current production from p/n 5-16037 et tube, sher-i-bronch, ls, 37 fr lot# 73e2200696 the samples were visually inspected and issue reported "blocked/obstructed - tracheal tubing" was not observed in the current manufacturing process.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
Qn# (b)(4).The customer returned (b)(4) unit 5-16039 et tube, sher-i-bronch, ls, 39 fr for investigation.The sample was returned without its original packaging.The stylet was also returned.Upon visual examination , no "fragment of plastic" that was reported was observed in the tube.It's possible that the fragment was not returned or it was lost during shipping/handling.Since the fragment was not observed in the returned ett and no pictures were provided, the reported complaint could not be confirmed.
Event or Problem Description
It was reported that: "presence of a fragment of plastic in the intubation tube whereas the patient was already intubated.This was monitored with a fibroscopy.The device was removed and replaced.There was no consequence for the patient.".

• 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
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14759671
• Report Number: 3003898360-2022-00227
• Device Sequence Number: 14979038
• Product Code: CBI
• UDI-Device Identifier: 14026704617415
• UDI-Public: 14026704617415
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180253
• 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): 05/30/2022

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: 12/11/2024
• Device Model Number: IPN048997
• Device Catalogue Number: 5-16039
• Device Lot Number: 73M1900266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2019
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FIBEROPTIC SCOPE.; FIBEROPTIC SCOPE.
• Patient Sex: Unknown