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

Catalog Number	198-39L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that the orientation port of a smiths medical portex® endotracheal tube was noted to be inclined more sharply.There were no reported adverse effects.
Additional Manufacturer Narrative
Three portex endotracheal tubes were returned for analysis; one returned in used condition without original packaging; one returned in used conditions with its original open packaging; one returned in new condition with its original closed packaging.Upon visual exam the two used samples were received without the stylet inserted, the new sample was received with the stylet inserted; no discrepancies were observed with the tip.The two returned used products were tested inside a plastic bag with a gauge and verified with the mandrel that was used in the procedure for bend and round tip operation, the new sample was tested without the plastic bag; no discrepancies were found.Relevant documents were reviewed and deemed adequate.An audit of the production floor was performed with no discrepancies noted.Operations were reviewed: training records of the operators that perform the bend and round tip operation were reviewed, training records of the operators that perform the stylet end form bent tube operation were reviewed, bend and round tip operation was reviewed, and stylet end form bent tube operation was reviewed; noting no discrepancies.The bend and round tip operation was audited during thirty two (32) units; the bend and round tip operation was performed according to the test method stated in the manufacturing procedure; no discrepancies in the orientation of the tube were detected during the thirty two (32) units tested.Based on the evidence, the root cause is unknown as the complaint is not confirmed.

• 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 n; minneapolis, MN 55442
• MDR Report Key: 7799659
• Report Number: 3012307300-2018-03521
• Device Sequence Number: 18878534
• Product Code: CBI
• UDI-Device Identifier: 15019315058639
• UDI-Public: 15019315058639
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 08/12/2019
• Device Catalogue Number: 198-39L
• Device Lot Number: 3261633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1