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

Model Number	100/597/080
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the purple introducer for the inner cannula is too big to push down the tube on this occasion.This happened with two from the same lot.Customer had to open a third tube which was a size 7 for the size 8 tube to be able to be inserted properly and resolve the issue.Reporter stated the issue was found while in use with a patient and "luckily, this was a control tracheostomy it could have been potentially life threatening in an emergency." there has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
One patient, two product malfunctions (b)(6) both represent the same patient.This is the second malfunction report for the related complaints.First malfunction reported under manufacturing report number 3012307300-2023-01649.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Additional Manufacturer Narrative
Udi updated - (b)(4).Device evaluation: investigation of this complaint was limited because no sample nor photo was provided.The customer is the most probably claiming that the purple introducer cannot be inserted to the tube.It is also described that in reaction to that customer inserted purple introducer of size 7 into the tube size 8 for easier insertion.Without the sample the true root cause of this issue is unable to be determined.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.For all enquiries or follow-up questions related to the record, do not use (b)(6).

• 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): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; shrewsbury business park; minneapolis, MN 55442
• MDR Report Key: 16438757
• Report Number: 3012307300-2023-01658
• Device Sequence Number: 16927989
• Product Code: BTO
• UDI-Device Identifier: 15019315107146
• UDI-Public: 15019315107146
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 07/01/2024
• Device Model Number: 100/597/080
• Device Catalogue Number: 100/597/080CZ
• Device Lot Number: 4134707
• Was Device Available for Evaluation?: No
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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