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

Model Number	IPN049000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found the connector broken before using on patient.Then changed to a new one.No impact on patient".
Additional Manufacturer Narrative
(b)(4).Per dhr the et tube, sher-i-bronch, ls, 35 fr lot # 73g2100252 was manufactured on (b)(6) 2021 a total of 716 pieces.Lot was released on (b)(4) 2021.Dhr investigation did not show issues related to complaint.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.

• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15770802
• Report Number: 3003898360-2022-00723
• Device Sequence Number: 20455494
• Product Code: CBI
• UDI-Device Identifier: 14026704617446
• UDI-Public: 14026704617446
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2026
• Device Model Number: IPN049000
• Device Catalogue Number: 5-16035
• Device Lot Number: 73G2100252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• 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: Unknown