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

Model Number	100/126/030
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number and expiration date and device manufacture date are unknown, no information has been provided to date.No product was returned and therefor we are unable to confirm the reported complaint.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review could not be performed as the device lot number is unknown.
Event or Problem Description
It was reported that a baby was intubated with a 3.0 endotracheal tube (ett).The customer went to go suction the baby and noticed it was unable to pass the 8fr catheter past the tapes.It is believed the tapes were tight so the customer had the tapes readjusted.After readjusting the tapes the customer was still unable to pass the 8 fr catheter.Tried another catheter but still couldn't get it down.Ended up having to put a 6fr suction catheter in.The endotracheal tube (ett) was removed and no issues passing an 8fr catheter.No injury was reported.

• Brand Name: PORTEX ENDOTRACHEAL 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): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16499718
• Report Number: 3012307300-2023-02135
• Device Sequence Number: 6611106
• Product Code: BTR
• UDI-Device Identifier: 15019315056765
• UDI-Public: 15019315056765
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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: 100/126/030
• Device Catalogue Number: 100/126/030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown