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

Model Number	100/897/070CZ
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tracheostomy procedure preparation, the user could not fully clamp the guidewire and was not able to close the adjustable flange issue was observed during device check and prior to use.There was no patient involvement reported.
Additional Manufacturer Narrative
One device was received for evaluation in relation to the reported event.Evaluation of the device is currently in progress.Once the evaluation is complete, a follow-up report with evaluation results will be submitted.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Similar customer complaints related to uniperc flange locking mechanism were received in past therefore (b)(4) was raised.This issue is currently monitored via customer complaint trend (b)(4).Dhr review was done, no issues related to the original complaint were found.

• Brand Name: PORTEX 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: 13802978
• Report Number: 3012307300-2022-04652
• Device Sequence Number: 4994307
• Product Code: BTO
• UDI-Device Identifier: 15019315107191
• UDI-Public: 15019315107191
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 03/09/2025
• Device Model Number: 100/897/070CZ
• Device Catalogue Number: 100/897/070CZ
• Device Lot Number: 3913799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• 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