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

Model Number 100/199/080

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the cuff was inflated in an unusual way.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two (2) product samples and two (2) photos were received for evaluation.Visual and functional testing were performed.Visual inspection found no defects in the photos and no defects in the samples.Functional testing found occlusion was detected in one sample due to an excess solvent and unusual inflation was observed due the occlusion.The root cause of the reported issue was found to be manufacturing.Awareness notification was made to production personnel to explain the importance to adherence or following in the procedure ?inflation line sub-assembly?, by quality engineer on 23/may/2022.

• Brand Name: PORTEX SOFT SEAL CUFF TRACHEAL TUBE
• Type of Device: 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 14252613
• MDR Text Key: 290405304
• Report Number: 3012307300-2022-07217
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 15019315022340
• UDI-Public: 15019315022340
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K790312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/199/080
• Device Catalogue Number: 100/199/080
• Device Lot Number: 4065673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1