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

Model Number	100/179/055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the customer attempted to put air in the cuff, but it would not be inflated.No patient involvement 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.Six (6) photos and two (2) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection of the photos found a cut on tip of the tube were observed in photo 5 and photo 6.Visual inspection of the samples found a cut on tip of the tube was detected in both samples.Functional testing found leakage was detected in both samples; the complaint was confirmed.The root cause of the reported issue was found to be end form tube bevel operation not followed properly.Awareness notification was made to production personnel to explain the importance to adherence or following in the procedure end form tube bevel operation, by quality engineer on 25/apr/2022.

• Brand Name: PORTEX 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14102451
• Report Number: 3012307300-2022-06296
• Device Sequence Number: 6371303
• Product Code: BTR
• UDI-Device Identifier: 15019315022098
• UDI-Public: 15019315022098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 08/01/2026
• Device Model Number: 100/179/055
• Device Catalogue Number: 100/179/055
• Device Lot Number: 4169638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2401-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown