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	Break (1069)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
One lung ventilation procedure on an overweight patient with a difficult airway.Patient was intubated and they were in midst of [the] procedure when [the] anesthesiologist heard a hissing noise; it was from the connector breaking.Patient began to desaturate and they had to remove the tube and reintubate.The occurrence forced the procedure to be cancelled".Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.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 one unit 5-16039 et tube, sher-i-bronch, ls, 39 fr for investigation.The et tube and both swivel connectors were returned.The y connector and suction catheters were not returned.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 15mm side.The swivel connector is a component purchased from a supplier.A non-conformance was previously opened to further investigate this issue.Corrective actions were implemented under the non-conformance on (b)(6) 2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.
Event or Problem Description
One lung ventilation procedure on an overweight patient with a difficult airway.Patient was intubated and they were in midst of [the] procedure when [the] anesthesiologist heard a hissing noise; it was from the connector breaking.Patient began to desaturate and they had to remove the tube and reintubate.The occurrence forced the procedure to be cancelled".Patient condition reported as "fine".
Event or Problem Description
One lung ventilation procedure on an overweight patient with a difficult airway.Patient was intubated and they were in midst of [the] procedure when [the] anesthesiologist heard a hissing noise; it was from the connector breaking.Patient began to desaturate and they had to remove the tube and reintubate.The occurrence forced the procedure to be cancelled".Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-16039 et tube, sher-i-bronch, ls, 39 fr for investigation.The et tube and both swivel connectors were returned.The y connector and suction catheters were not returned.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 15mm side.The swivel connector is a component purchased from a supplier.A non-conformance was previously opened to further investigate this issue.Corrective actions were implemented under the non-conformance on 08jan2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.Corrected data: section h.6.-type of investigation - code 3331 removed as it was entered in error.

• 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
• MDR Report Key: 13446563
• Report Number: 3003898360-2022-00012
• Device Sequence Number: 4321706
• Product Code: CBI
• UDI-Device Identifier: 14026704617415
• UDI-Public: 14026704617415
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN048997
• Device Catalogue Number: 5-16039
• Device Lot Number: UNKNOWN
• 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: 01/11/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 04/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/08/2022; 04/08/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown