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

Model Number	503060
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when changing the patients trach, the pilot balloon port did not accept the syringe.Multiple sized syringes were used and none fit the port.The april delivery ports are all the same vs the march delivery of ports.The march ports were able to fit syringes.When compared, the ports were different sizes.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the sample luer was noticeably tapered.Functional testing found the cuff port would not attach to the luer slip fitting.Using a 6" caliper, the od and id of the sample was measured (od-0.285 mm; id-0.140 mm) and compared to a new unsterilized (od-0.258 mm: id-0.160 mm) cuff port.The returned sample had smaller readings (undersized) and a milky white coloring was noted.The root cause of the issue could not be determined with any certainty at what point this defect occurred.However, as a precaution, a quality alert was issued to production to heighten awareness to this potential issue and the sample was forwarded for secondary investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: PORTEX
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14576969
• Report Number: 3012307300-2022-10503
• Device Sequence Number: 5041513
• Product Code: BTR
• UDI-Device Identifier: 10351688017772
• UDI-Public: 10351688017772
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 503060
• Device Catalogue Number: 503060
• Device Lot Number: 4168581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/05/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/17/2022
• 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