MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. CATHETER; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907); Separation Problem (4043)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.There was no catheter disconnection confirmed, and it was confirmed that the product connector complies with the product standards.The reported issue could not be confirmed.Brand name, common device name, model #, initial reporter, report source, and protocol # are unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during the use of the product, the customer noticed the catheter slipped off from the connector.No patient injury was reported.

Manufacturer Narrative

Other text: this remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4), corrected data: corrected information provided in d2.

• Brand Name: CATHETER
• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 15321747
• MDR Text Key: 305430048
• Report Number: 3012307300-2022-16560
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/06/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1