MAUDE Adverse Event Report: ST PAUL PORTEXPORTEX ENDOTRACHEAL TUBES SILICONIZED; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/166/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone number: (b)(6).
Event or Problem Description
Information was received indicating that a smiths medical product was leaking air.There was no patient injury reported.There were no adverse events reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Visual and functional tests were performed.One device and four pictures were returned for investigation.Physical evaluation of the device showed a bite mark in the inflation line.Inflation line damage was observed in photo 1 and photo 2; the complaint was confirmed.The sample was received in used conditions without its original package.The returned sample was visually inspected at 12 to 16 inches and normal conditions of illumination.Inflation line damage was found, and a bitten mark was found where the tube is cut, the complaint was confirmed.The root cause analysis leads to user error as this lot number went through and passes all required inspections.No action taken required since the failure mode reported is not attributable to the manufacturing process.
Event or Problem Description
Additional information was received: the event occurred during use of the product.The tube was replaced to resolve the reported issue.There was no infusion device used during the event.

• Brand Name: PORTEXPORTEX ENDOTRACHEAL TUBES SILICONIZED
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 11881657
• Report Number: 3012307300-2021-05046
• Device Sequence Number: 11683888
• Product Code: BTR
• UDI-Device Identifier: 15019315054099
• UDI-Public: 15019315054099
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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 Model Number: 100/166/075
• Device Catalogue Number: 100/166/075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 08/01/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian