MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	100/870/075
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a "trache team ward rounding" a cuff pressure leak was investigated by "icu/trache team consultant and a/ cnc.Cuff pressure was checked and found to be lower than "20cmh2o".Cuff was re-inflated and rechecked after 30mins and was lower than "22cmh2o".Decision was made to change tracheostomy tube a week before it was due for a change.No injury reported.
Additional Manufacturer Narrative
Other, other text: 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.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One device was received without its original packaging, decontaminated and inside in a plastic bag.Per visual inspection, no unusual conditions were detected.Per functional testing, the device passed the leak test.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 since the complaint was not confirmed.
Additional Manufacturer Narrative
D4: udi updated.Udi related data quality updates only.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY KIT
• 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: 18047879
• Report Number: 3012307300-2023-10110
• Device Sequence Number: 8076994
• Product Code: BTO
• UDI-Device Identifier: 15019315038792
• UDI-Public: (01)15019315038792(11)211206(17)261112(10)4217111
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030570
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/870/075
• Device Catalogue Number: 100/870/075CZ
• Device Lot Number: 4217111
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/10/2023
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 01/08/2024; Not provided
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 02/14/2024; 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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