MAUDE Adverse Event Report: HUDSON ET TUBE, SHER-I-BRONCH, LS, 41 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN048998
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A visual inspection of the product involved in the complaint was performed on two pictures received by the customer of product code 5-16041 (et tube, sher-i-bronch, ls, 41 fr).From the pictures attached it was confirmed the defect reported by the customer "other / broken tube".However it is necessary to receive the physical sample to perform a proper investigation, determine root cause & implement corrective actions.A verification of failure mode reported in the current manufacturing process was conducted as follows: 50 samples were taken from the current production (material # 5-16041 lot # 73h2100163); the samples were visually inspected and issue reported "other / broken tube" was not observed in the current manufacturing process.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.
Event or Problem Description
During use on a patient, the 41fr tubes were found to be "broken".It was reported the "patient desaturated into the 50's before we could figure out the problem and get a replacement".The replacement was also found "broken in package during a critical moment and due to the delay it causes to the procedure as the tubes need to be exchanged".Third 41fr ett "fortunately worked".Connector piece reported to be replaced.Patient condition unknown at time of report.Multiple attempts for additional information to the customer has been unsuccessful.

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, LS, 41 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• MDR Report Key: 12406420
• Report Number: 3003898360-2021-00808
• Device Sequence Number: 20116423
• Product Code: CBI
• UDI-Device Identifier: 14026704617422
• UDI-Public: 14026704617422
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: No Information
• Device Model Number: IPN048998
• Device Catalogue Number: 5-16041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention