MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Catalog Number	198-32L
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that immediately after starting to use the product, there was a suspected air leak from the swivel adapter.After the customer removed the adapter, the air leak was no longer observed.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: one (1) used sample was returned for evaluation p/n 198-32l l/n 3748956; the sample was received in used condition no discrepancies were observed.During testing: the test for te iso insertion depth was performed to the swivel connector.The test for te iso insertion depth was performed to the swivel connector; the test result was 7.5 lbs; the result is within specification since is between 7.1 lbs and 8.7 lbs acording to md01-106 rev 002 test for iso insertion depth.The internal diameter of the swivel connector was measured and the result was 0.408 in ; the results is withing specification (0.408 +0.003 -0.000) acording to pd 225-2421-500 rev 000 drawing body, single axis swivel.The customer reported condition was not confirmed.No fault found.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8689872
• Report Number: 3012307300-2019-03637
• Device Sequence Number: 1643995
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: No Information
• Device Expiration Date: 01/09/2022
• Device Catalogue Number: 198-32L
• Device Lot Number: 3748956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1