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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

It was reported that there is a clinician misuse issue, stating the procedure for the ciaglia technique is "almost never followed".The clinician began to make a horizontal or vertical incision instead of starting to identify and mark the anatomical landmarks.It was reported that the clinician reversed steps 3 and 4 in the ifu.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Catalog number, lot number, expiration date, and udi section and h4 are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Manufacturer Narrative

Event problem and evaluation codes updated.No product was returned and are unable to confirm the reported complaint.If the product is returned, the complaint file will be re-opened for further investigation.A manufacturing device history record (dhr) review was not performed because the device lot number was not provided.

• Brand Name: PORTEX TRACHEOSTOMY CARE KIT
• 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: 16305512
• MDR Text Key: 308933006
• Report Number: 3012307300-2023-00907
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2023
• 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