MAUDE Adverse Event Report: ST PAUL BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/131/070
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Airway Obstruction (1699); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that, just after bringing a patient through to theatre it was noticed that there was a leak from the patients endo tracheal tube.Patient reintubated with an armoured tube.There was no patient injury.
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that, just after bringing a patient through to theatre it was noticed that there was a leak from the patients endo tracheal tube.Patient reintubated with an armoured tube.There was no patient injury.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Per visual inspection, no defects were found in two samples and leak test cannot be perform since the samples returned incomplete; complaint was not confirmed.Root cannot be addressed since no defects were found in sample received for evaluation.No actions were taken since the complaint was not confirmed.No problems or issues were identified during this device history record review.

• Brand Name: BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
• 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; minneapolis, MN 55442
• MDR Report Key: 13472773
• Report Number: 3012307300-2022-02794
• Device Sequence Number: 5233238
• Product Code: BTR
• UDI-Device Identifier: 15019315057236
• UDI-Public: 15019315057236
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2025
• Device Model Number: 100/131/070
• Device Catalogue Number: 100/131/070
• Device Lot Number: 3981501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown