MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY/PVC PORTEX TUBES- BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/800/060

Device Problem Inflation Problem (1310)

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

Event Date 04/21/2020

Event Type  malfunction  

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 this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported when the customer was inflating the cuff at a pre-use check, he noticed it got deformed.No patient injury was reported.

• Brand Name: TRACHEOSTOMY/PVC PORTEX TUBES- BLUSELECT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-3-2 kamiochiai, chuoh-ku,; minneapolis, MN 55442
• MDR Report Key: 15461727
• MDR Text Key: 303584300
• Report Number: 3012307300-2022-19942
• Device Sequence Number: 1
• Product Code: BTO
• 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,Consumer
• 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 Expiration Date: 06/01/2004
• Device Catalogue Number: 100/800/060
• Device Lot Number: 3834855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1