MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 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	09/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.However, it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.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: 80 samples were taken from the current production; 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
It was reported that: "the nurse found connector broken when opening the package before using on patient.Then changed new one.No impact on patient.".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-16035 et tube, sher-i-bronch, ls, 35 fr for investigation.The et tube was returned in its original packaging.Both double swivel connectors and the y connector were returned out of their original packaging.The suction catheters were not returned.The returned connectors were visually examined with and without magnification.Visual examination of the returned sample revealed that the tracheal swivel connector was broken on the 15mm 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.
Event or Problem Description
It was reported that: "the nurse found connector broken when opening the package before using on patient.Then changed new one.No impact on patient.".No patient involvement.

• Brand Name: HUDSON 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15572814
• Report Number: 3003898360-2022-00517
• Device Sequence Number: 19559816
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 08/16/2026
• Device Model Number: IPN049000
• Device Catalogue Number: 5-16035
• Device Lot Number: 73H2100162
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/10/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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