MAUDE Adverse Event Report: ST PAUL PORTEX UNCUFFED MURPHY EYE ORAL/NASAL ENDOTRACHEAL; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/127/030
Medical Device Problem Codes	Complete Blockage (1094); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: month and year of event have been provided, day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the customer experienced an issue with the product.The "8fr" inline suction catheter could not pass through the tube.After discovering the problem, nicu replaced the catheter it with a "7fr" catheter with "no issues".Further investigation revealed that the affected ett had a flat side.Adverse effects were not reported.
Additional Manufacturer Narrative
Device evaluation; no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation., corrected data: g2 email is: regulatory.Responses@icumed.Com.
Additional Manufacturer Narrative
D4: udi updated.**udi related data quality updates only**.

• Brand Name: PORTEX UNCUFFED MURPHY EYE ORAL/NASAL ENDOTRACHEAL
• 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
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18193642
• Report Number: 3012307300-2023-10736
• Device Sequence Number: 7790666
• Product Code: BTR
• UDI-Device Identifier: 15019315019814
• UDI-Public: (01)15019315019814(11)220602(17)270518(10)4225686
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024

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 Catalogue Number: 100/127/030
• Device Lot Number: 4225686
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 01/25/2024; Not provided
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/23/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown