MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/860/080CZ

Device Problem Leak/Splash (1354)

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

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that during the use of the product, leakage of air from the cuff was observed.No patient injury.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.One used decontaminated sample was received for evaluation.The sample was received in a plastic bag without its original packaging.Visual and functional testing was performed.Under visual inspection the sample appeared to be in good condition.The inflation test was repeated on the received sample.It was found that the sample cannot pass this 12-hour test - cuff was deflating during inflation.Source of leak was found to be tear in cuff.Each cuff shall be also tested by customer prior use as per instruction for use (ifu), "check the integrity of the cuff and inflation system prior to insertion." due to fact that cuff leak was not observed prior use it is the most probable that reported failure occurred during tracheostomy procedure or during use.This root cause of the reported issue was undetermined.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• Type of Device: TUBE, TRACHEOSTOMY (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; minneapolis, MN 55442
• MDR Report Key: 14160007
• MDR Text Key: 289615947
• Report Number: 3012307300-2022-06683
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Device Lot Number: 4186574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention