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

Model Number	100/166/080
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.One sample returned in used condition and without its original packaging.Visual inspection performed at a distance of 12 to 16 inches and normal conditions of illumination and no discrepancies were observed.Functional testing of the returned sample was inflated using a syringe in order to detect any leakage.And there leakage was observed coming out from the seal of the cuff.The root cause was linked to manufacturing.Actions were taken to mitigate the reported issue.Per previous in-process discrepancy report update the procedure was updated and re-training of manufacturing personnel occurred.This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.
Event or Problem Description
It was reported that during a pre-use check on the device, the customer noticed the cuff would not inflate.No patient injury was reported.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SILICONIZED
• 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: 15635245
• Report Number: 3012307300-2022-25206
• Device Sequence Number: 12211775
• Product Code: BTR
• UDI-Device Identifier: 15019315054105
• UDI-Public: 15019315054105
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 100/166/080
• Device Catalogue Number: 100/166/080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown