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

Model Number	100/189/070
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the hospital experimented on the product after cases of micro aspirations, and found that cuffs were leaking.The functionality tests were performed in the presence of a smiths rep and it was observed that inflated cuffs showed leaks and bubbles when immersed in transparent container filled with water.Additionally, it was alleged the spring valve of the pilot balloon wasn't working right.The test was done in 189 and 199.They blew the cuff with air at 30 cm as recommended on the tube, then detached the manometer.They reconnected the manometer and after a second and observed that the reading dropped 26cm in size 7 and 8 et.The pressure was not getting stabilized and was continuously dropping.This is the same thing they are experiencing at patient bedside thought they were maintaining the cuff pressure for 3 times a day and still having vap case.Also tried to use 199 plain et and found the pressure was not getting stable, continuously dropping.They used 10 units to assess the functionality with the same outcome.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
Additional Manufacturer Narrative
H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two samples and five photos were received for evaluation.Visual and functional testing found no leakage were detected in two samples; complaint was not confirmed.Devices passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; thousand lights,; minneapolis, MN 55442
• MDR Report Key: 14761093
• Report Number: 3012307300-2022-12327
• Device Sequence Number: 6021726
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: 15019315059520
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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 Expiration Date: 02/03/2026
• Device Model Number: 100/189/070
• Device Catalogue Number: 100/189/070
• Device Lot Number: 4103881
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2021
• 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