MAUDE Adverse Event Report: PORTEX; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-39L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after intubation, broncocath did not adequately ventilate and needed replacement, when removing an anesthetist noticed that the balloon was damaged.No adverse patient effects were reported.
Event or Problem Description
Investigation completed and summary in h 10.
Additional Manufacturer Narrative
Investigation completed on a smiths medical intubation|portex endobronchial tubes.The complaint was visually inspected in a photo and sample from lot p/n 100/189/080 was tested, and found cuff damage.The cuff tear occurs, during tracheostomy procedure, due to contact with sharp edge.Which conflicts with ifu warnings, section 4.1: "both the tracheal and bronchial cuff inflation systems should be tested for function and leaks before intubation.Cuff leaks that are detected immediately following tube placement are usually, due to cuff nicks from teeth or instrumentation, during intubation.True cuff leaks may require reintubation and placement of a new endobronchial tube.No corrective action is required, since the product no leaks in the pre-checked according to the instruction for use.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• MDR Report Key: 11632256
• Report Number: 3012307300-2021-02925
• Device Sequence Number: 3547293
• Product Code: CBI
• UDI-Device Identifier: 15019315058639
• UDI-Public: 15019315058639
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 08/15/2022
• Device Model Number: 198-39L
• Device Catalogue Number: 198-39L
• Device Lot Number: 3867273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2019
• 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