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

Model Number	100/597/080CZ
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One portex uniperc percutanous kit and tracheostomy tube was returned for analysis in good condition.The outer diameter was measured 10 different time in different areas; confirming that the results were within specifications.Instructions for use (ifu) were reviewed.Based on the evidence the allegation was not confirmed.However, the root cause was believed to be due to assembly was done without lubrication which was is a conflict with the ifu.
Event or Problem Description
Information was received indicating that during placement of a smiths medical portex uniperc percutanous kit and tracheostomy tube, it was reported the obturator was unable to be inserted into the trach tube.There were no reported adverse effects.

• Brand Name: PORTEX UNIPERC PERCUTANOUS KIT AND TRACHEOSTOMY TU
• 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
• MDR Report Key: 10296434
• Report Number: 3012307300-2020-07423
• Device Sequence Number: 19543451
• Product Code: BTO
• UDI-Device Identifier: 15019315107146
• UDI-Public: 15019315107146
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2020

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: No Information
• Device Model Number: 100/597/080CZ
• Device Catalogue Number: 100/597/080CZ
• Device Lot Number: 3893549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1