MAUDE Adverse Event Report: ST PAUL PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the year (2020) of the event date is known.(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that the cuff pressure dropped on the portex endotracheal tube.The cuff did not re-inflate after it was supplied with air.This product problem was observed during patient use.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical intubation|portex endotracheal tubes siliconized.Two photos were received.Sample for evaluation p/n 100/166/070 was visually inspected and no defects were observed under normal visual specifications.Functional testing completed with injecting air in balloon and submerging under water.No leaking upon inflation or submerging.The device passed at 100% prior to release of product.No fault was found or established.
Event or Problem Description
Investigation completed and summary in h 10.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11030435
• Report Number: 3012307300-2020-12530
• Device Sequence Number: 19131086
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• 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): 03/15/2021

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 Model Number: 100/166/070
• Device Catalogue Number: 100/166/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1