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

Model Number	100/562/000
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the guide wire would not fit through the access needle with any possibility.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Health effects and evaluation codes: updated.Email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.It is possible that the customer tried to insert guidewire directly into needle which is not correct per the instructions for use (ifu).Unfortunately, without the sample we are not able to determine true root cause of this issue.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX TUBES PDT ULTRAPERC
• 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): NULL; 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: 16548089
• Report Number: 3012307300-2023-02532
• Device Sequence Number: 14963247
• Product Code: JOH
• UDI-Device Identifier: 15019315106750
• UDI-Public: 15019315106750
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K040014
• 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,Followup
• Report Date (Section B): 02/20/2024

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: 10/01/2024
• Device Model Number: 100/562/000
• Device Catalogue Number: 100/562/000CZ
• Device Lot Number: 4183960
• Was Device Available for Evaluation?: No
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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