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

Model Number	100/597/080CZ
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.No product sample was received; therefore, visual and functional testing could not be performed.Similar customer complaints related to the flange locking mechanism were received in past therefore an internal ncr was raised.This issue is currently monitored via trend analysis.If the occurrence of this issue increases significantly, additional corrective actions will be taken.
Event or Problem Description
It was reported that the clamp to block the tube was defective.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

• Brand Name: PORTEX TUBES PDT UNIPERC
• 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: 15494697
• Report Number: 3012307300-2022-20411
• Device Sequence Number: 14763010
• Product Code: BTO
• UDI-Device Identifier: 15019315107146
• UDI-Public: 15019315107146
• Combination Product (Y/N): N
• Initial Reporter Country: NC
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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: 11/01/2024
• Device Model Number: 100/597/080CZ
• Device Catalogue Number: 100/597/080CZ
• Device Lot Number: 4211969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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