MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. IVORY PVC, NASAL, SOFT SEAL CUFF TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/179/055
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intubation for dental surgery the customer had to use three (3) tubes on the one patient, each time there were leaks.The balloon had always been checked beforehand.The leak came directly from the blue tube.The customer did leak tests in water to see and discovered a small hole in the tube and not in the balloon on each one.Throat edema was also noted from the reporter.Additional information was requested; however, no further information was received.
Additional Manufacturer Narrative
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.Device lot number is unknown, no product information has been provided to date.
Additional Manufacturer Narrative
Other, other text: no product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.No lot number was provided for performance of a device history record review.

• Brand Name: IVORY PVC, NASAL, SOFT SEAL CUFF TRACHEAL TUBE
• 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: 15306357
• Report Number: 3012307300-2022-16443
• Device Sequence Number: 12106146
• Product Code: BTR
• UDI-Device Identifier: 15019315022098
• UDI-Public: 15019315022098
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K790312
• 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): 11/03/2022

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 Model Number: 100/179/055
• Device Catalogue Number: 100/179/055
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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