MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOBRONCHIAL TUBES; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-37L
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the white cuff was unable to be deflated.No patient injury was reported.Additional information: body fluid was attached to the returned product therefore the event likely to have occurred during use.No patient injury occurred and the reports issue was resolved by replacing the tube.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Three pictures were attached, during the analysis conducted it could be observed a top view of the product in one of them.In the others a focus on cuff was performed and a damaged can be appreciate; there were not conditions to corroborate difficult to deflate it.The returned sample was visually inspected at 12 to 16 and normal conditions of illumination according, inspection procedure.Damage on cuff was observed.The cuff and balloon pilot of the sample received was tried to inflate according to the recommendations on information for use using a syringe in order to evaluate the cuff.A test could not be performed due to the fact that the sample was not received in condition to perform a functional test.The damage detected on the cuff does not allow to inflate the cuff in order to try if it can be deflated by normally.No root cause has to be determined since the reported failure mode was not confirmed due to the fact that the sample was not received in conditions to perform a thorough investigation.No corrective actions are required since the complaint was not confirmed.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16828448
• Report Number: 3012307300-2023-04703
• Device Sequence Number: 11248418
• Product Code: CBI
• UDI-Device Identifier: 15019315058622
• UDI-Public: 15019315058622
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 09/01/2024
• Device Model Number: 198-37L
• Device Catalogue Number: 198-37L
• Device Lot Number: 4184844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown