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

Model Number	100/199/065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported, that there was an air leak.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Other text: d10, h3, h6 - evaluation codes: updated.Device evaluation: one device, in used condition without it's original packaging, was received for investigation.Visual inspection detected damage to the tip.The sample failed a leak test.Based on the analysis conducted in the sample provided, failure mode leaking was confirmed.According with the occurrence of this failure condition root cause could be machine failure at time of manufacture.A review of the device history record (dhr) showed, at the time of manufacture, there were no observations or nonconformities recorded to suggest an issue of this nature would occur with this lot of products.All mitigations on place were verified and it was confirmed has been executed according.Complaints will continue to be monitored for this failure condition, in this product for threshold or escalation.Notification to operations personnel as awareness was performed.

• Brand Name: SILICONISED PVC ORAL/NASAL SOFT CUFF TRACHEAL
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17043182
• Report Number: 3012307300-2023-05949
• Device Sequence Number: 5178326
• Product Code: BTR
• UDI-Device Identifier: 15019315022319
• UDI-Public: 15019315022319
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 100/199/065
• Device Catalogue Number: 100/199/065
• Device Lot Number: 4299366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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