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

Catalog Number	C45101796D-NL
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the portex® clear pvc, oral/nasal, profile soft seal® cuff tracheal tubes were "failing" during surgery.According to the reporter, the tracheal tubes would not hold inflation and would leak.The patients were re-intubated during surgery.No adverse event was reported.Related mfr #'s: 3012307300-2017-00480, 3012307300-2017-00481.

• Brand Name: PORTEX® TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6341341
• Report Number: 3012307300-2017-00482
• Device Sequence Number: 13855691
• Product Code: BTR
• UDI-Device Identifier: 15019517069990
• UDI-Public: 15019517069990
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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: Health Professional
• Device Catalogue Number: C45101796D-NL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1