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

Model Number	100/870/080CZ
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One used decontaminated sample 007/910/880 8mm 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 was not completed since no fault was found.
Event or Problem Description
It was reported that the patient had a leaking tracheostomy tube cuff.The patient required an earlier tracheostomy change.Upon decannulation, the hcp noted that a 'build of bubble' was noted within the cuff.No injury to the patient.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14193983
• Report Number: 3012307300-2022-06938
• Device Sequence Number: 4333018
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 07/07/2026
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 4155447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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