MAUDE Adverse Event Report: ST PAUL PORTEX; TRACHEAL TUBE

Model Number	100/166/070
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical trach was unable to be inflated at the cuff during a pre-use check.In addition, the shape of the inflated was different from usual.There was no patient injury.
Additional Manufacturer Narrative
Other, other text: device evaluation- the device was returned for evaluation.The examination of the device showed no defects.The device was given functional testing and the cuff could not be inflated.The review of the device hazard analysis indicated the device issue could have been caused by solvent application being performed incorrectly.However, the review of the manufacturing process confirmed this device type's inflation system leak mitigation's were all being followed appropriately.The cause of the issue was potentially identified as manufacturing.

• Brand Name: PORTEX
• Common Device Name: TRACHEAL TUBE
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11041355
• Report Number: 3012307300-2020-12573
• Device Sequence Number: 1024094
• Product Code: BTR
• UDI-Device Identifier: 15019315054082
• UDI-Public: 15019315054082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/27/2021

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 Lot Number: 3962908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1