MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX ENDOTRACHEAL TUBES POLAR; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/133/075
Medical Device Problem Codes	Tidal Volume Fluctuations (1634); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: d3, g1,2 email is: (b)(4).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 there was a "loss of tidal volume during general anesthesia.Balloon pressure was maintained.Volume occurs several times with balloon flat.Decision to reintubate for further surgery and intubation, which will last a minimum of 24 hours".The customer said that the operator of the device was a health professional.No clinical consequences for the patient and no medical treatment.Interruption of surgery for 20 minutes during reintubation on guide.Need for re-intubation on guide during the procedure due to balloon leak, without "difficulty".The outcome of the injury was reported as resolved.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One device sample was received in used condition without the original packaging.Per visual inspection, no visual defects were identified in the sample.Per functional testing, the sample passed the test.No leaks were observed.The complaint was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken as the complaint could not be replicated and the device functioned as intended.The failure mode will continue to be monitored and if a trend is identified further investigation will be performed.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PORTEX ENDOTRACHEAL TUBES POLAR
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18326506
• Report Number: 3012307300-2023-11062
• Device Sequence Number: 7520305
• Product Code: BTR
• UDI-Device Identifier: 15019315020360
• UDI-Public: (01)15019315020360(11)221020(17)271003(10)4325759
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K931735
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100/133/075
• Device Catalogue Number: 100/133/075
• Device Lot Number: 4325759
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/11/2023
• 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: 11/16/2023
• Supplement Date Received by Manufacturer: 01/23/2024; Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/27/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown