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

Model Number	513070
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach does not inflate, when put in water, you can see there is a hole in it.Not used on a patient.
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and 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.
Additional Manufacturer Narrative
Other, other text: one device was received for investigation.Visual inspection did not reveal any defects.Leakage was observed immediately during the leak test.Further investigation using magnification revealed a slight tear in the cuff material; the complaint was confirmed.While the leakage of the cuff was confirmed it could not be determined with any certainty at what point this defect occurred.Root cause could not be determined.One year complaint history review since september 2021 revealed no trends for this product and problem category.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.

• Brand Name: PORTEX TUBES DIC
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15383272
• Report Number: 3012307300-2022-18218
• Device Sequence Number: 17500161
• Product Code: BTR
• UDI-Device Identifier: 10351688023544
• UDI-Public: 10351688023544
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

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: 02/28/2026
• Device Model Number: 513070
• Device Catalogue Number: 513070
• Device Lot Number: 4168591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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