MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEOSTOMY

Model Number 100/870/080CZ

Device Problem Inflation Problem (1310)

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

Event Date 04/24/2020

Event Type  malfunction  

Event Description

It was reported that the device had no end cap of pilot balloon.No patient injury reported.

Manufacturer Narrative

A product sample was received for evaluation.Investigation 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.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15461109
• MDR Text Key: 305429284
• Report Number: 3012307300-2022-19913
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 3845493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1