MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUSELECT TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/870/075CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One used decontaminated sample (b)(4) 7.5mm deht blu suctionaid sub-assy was returned for investigation without its original packaging.Under visual inspection the sample appeared to be in good condition.During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed.No trend of similar customer complaints was identified.A dhr review summary was not completed as no fault was found.
Event or Problem Description
It was reported that immediately after the customer was intubated the artificial respirator issued and air leak alarm.The device was changed to resolve the issue.No patient injury.No further information available for this complaint.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 14635476
• Report Number: 3012307300-2022-11198
• Device Sequence Number: 5980848
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: 15019517076219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2022

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 Expiration Date: 11/27/2025
• Device Model Number: 101/870/075CZ
• Device Catalogue Number: 101/870/075CZ
• Device Lot Number: 4061022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2020
• 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