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

Model Number	IPN048996
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported issue: the doctor found the connector broken when in a clinical setting before using it on a patient.A new one was used.No impact on patient.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The manufacturer reports a verification of failure mode reported in the current manufacturing process was conducted as follows: 50 samples were taken from the current production from p/n 5-16037 et tube, sher-i-bronch, ls, 37 fr lot# 73a2300767 the samples were visually inspected and issue reported broken/cracked - double swivel connector 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.
Event or Problem Description
Reported issue: the doctor found the connector broken when in a clinical setting before using it on a patient.A new one was used.No impact on patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.The y connector and both swivel connectors were returned out of their original packaging.The et tube and two suction catheters were returned in their original packaging.The returned connectors were visually examined with and without magnification.Visual examination of the returned samples revealed that the tracheal swivel connector was broken on the 22mm side.The reported complaint is confirmed based on the sample received.The tracheal swivel connector was broken on the 22mm side.The swivel connector is a component purchased from a supplier.A capa was previously opened to further investigate this issue.Corrective actions were implemented under the capa on 15apr2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

• Brand Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16448456
• Report Number: 3003898360-2023-00263
• Device Sequence Number: 14806845
• Product Code: CBI
• UDI-Device Identifier: 14026704617408
• UDI-Public: 14026704617408
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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 Model Number: IPN048996
• Device Catalogue Number: 5-16037
• Device Lot Number: 73E2200756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; NONE REPORTED
• Patient Sex: Unknown