MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLU SELECT CUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/800/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: d4: expiration date and h4: manufacture date are unknown, no information has been provided to date.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 while in use with a patient, "air was evacuated from the cuff".Resolution and adverse effects are unknown.The reported lot number cannot be verified.Additional information was requested; however, no further specific details and verification of reported product information involved in this incident was received.No patient injury or adverse affects were reported.
Additional Manufacturer Narrative
D4.Expiration date and h4.Manufacture date; updated.H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.One decontaminated device sample was received.Per visual inspection the sample appeared to be in good condition.A functional inflation test was performed on the received sample.It was confirmed that after twelve (12) hours the cuff was still fully inflated.The complaint was not confirmed.The reported lot number was not a valid lot number however there was a lot number (4305947) laser printed on tracheostomy tube flange.With this information we were able to review the device history record (dhr).A dhr review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken since the complaint was not confirmed.
Additional Manufacturer Narrative
D4: insufficient information was provided to be able to determine the full udi.**udi related data quality updates only**  .

• Brand Name: PORTEX BLU SELECT CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 18133988
• Report Number: 3012307300-2023-10487
• Device Sequence Number: 7581375
• Product Code: BTO
• UDI-Device Identifier: 15019517076073
• UDI-Public: 15019517076073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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 Model Number: 101/800/070
• Device Catalogue Number: 101/800/070CZ
• Device Lot Number: 4070042
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2023
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 11/28/2023; Not provided
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/27/2023; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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