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	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check, the customer noticed the orientation of the tube's fore end part was different from that of other normal ones.Also, the entire part of the tube was found excessively curved.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: three (3) photographs were received for evaluation.Result: from photographs received is observed a new closed sample and a used sample without stylet with a different tip orientation than the new sample.Sample received by sm: the returned sample consists of one (1) product p/n 198-32l l/n 3715075; the returned sample was received in used condition.During visual inspection no discrepancies were observed with the tip.During testing the returned product was tested and didn't fit in the test gauge.The customer reported condition was confirmed.Problem source is unknown.Engineer on (b)(6) 2019.

• 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: 8689889
• Report Number: 3012307300-2019-03639
• Device Sequence Number: 13957543
• 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
• Report Source: user facility
• 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: 10/09/2021
• Device Catalogue Number: 198-32L
• Device Lot Number: 3715075
• 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