MAUDE Adverse Event Report: HUDSON ET TUBE, SHER-I-BRONCH, RS, 39 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF

Model Number	IPN049002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 "the doctor found connector broken in clinical setting before using on patient".No patient involvement reported.
Event or Problem Description
It was reported "the doctor found connector broken in clinical setting before using on patient".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-16139 et tube, sher-i-bronch, rs, 39 fr for investigation.The et tube was also returned with the double swivel valve connector assembly (both swivel valves and y connector) and two suction catheters.All devices were returned in their original packaging.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the connector on the tracheal side of the swivel valve was broken inside the packaging.The swivel valve is a component purchased from a supplier.The reported complaint is confirmed based on the sample received.The connector on the tracheal side of the swivel valve was broken inside the packaging.The swivel valve is a component purchased from a supplier.A non-conformance and a scar (supplier corrective action request) were opened to further investigate this issue.Corrective actions were implemented under a scar in (b)(6) 2019 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.

• Brand Name: HUDSON ET TUBE, SHER-I-BRONCH, RS, 39 FR
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFF
• MDR Report Key: 11381793
• Report Number: 3003898360-2021-00134
• Device Sequence Number: 11802891
• Product Code: CBI
• UDI-Device Identifier: 14026704617460
• UDI-Public: 14026704617460
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: 06/25/2023
• Device Model Number: IPN049002
• Device Catalogue Number: 5-16139
• Device Lot Number: 73F1800555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2018
• 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