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

Model Number	100/870/085CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor found the cuff leaked during testing process.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Inflation testing was performed.It was found that it is not even possible to inflate cuff as it leaks so badly.Source of the leak was identified to be a hole in the cuff.The root cause of the reported issue was found to be manufacturing.Corrective actions have been taken including initiation of quality alert, training of whole production during production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.Reported lot number was manufactured (september 2021) prior implementation of corrective actions (december 2021).

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUB
• 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; bangna-trad road; minneapolis, MN 55442
• MDR Report Key: 14831198
• Report Number: 3012307300-2022-12579
• Device Sequence Number: 4833385
• Product Code: BTO
• UDI-Device Identifier: 15019315104879
• UDI-Public: 15019315104879
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 09/09/2026
• Device Model Number: 100/870/085CZ
• Device Catalogue Number: 100/870/085CZ
• Device Lot Number: 4170890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian