MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES BLUE LINE CLASSIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/523/060

Device Problem Leak/Splash (1354)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

Premarket (510k) number: information is not available.Device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported the nurse found the cuff leaked while testing before use.No patient injury was reported.

Manufacturer Narrative

Other text: a1, d10.Device available for evaluation; h3.Device evaluated by manufacturer and h6.Health impact, and evaluation codes: updated.One device was received in used condition without the original package.Per visual inspection, no damage was found on the components, no contamination, no failure mode conditions were observed.Functional testing observed a leak.The complaint was confirmed.The root cause was cuff leakage due to damage by handling with potential cause of wrong handling of the product from manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Awareness was made to operation personnel and the issue will be monitored for threshold or escalation.

• Brand Name: PVC - PORTEX TUBES BLUE LINE CLASSIC
• 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; bangna-trad road, bangna nuea; minneapolis, MN 55442
• MDR Report Key: 15808874
• MDR Text Key: 304094841
• Report Number: 3012307300-2022-27271
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 100/523/060
• Device Lot Number: 4056495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 04/02/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1