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

Device Problems Detachment of Device or Device Component (2907); Premature Separation (4045)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol b10009704, as a result of warning letter cms# (b)(4).No lot number was provided; therefore, device history record review could not be completed.The customer did not provide any product sample.Evaluation of the provided photo found the compromised catheter securement device: the locking mechanism was detached from the pad.Although the condition, reported by the customer, was observed, no further investigation could be performed without the actual sample evaluation and it could not be determined when how the device was compromised.Catalog number is unknown.Udi information is unknown.Premarket (510k) number is unknown.

Event Description

It was reported that during the use of product the plastic lock detached and the catheter had to be removed.No patient injury was reported.

• Brand Name: PEDIATRIC EPIDURAL TRAYS
• 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; minneapolis, MN 55442
• MDR Report Key: 15587313
• MDR Text Key: 301569341
• Report Number: 3012307300-2022-23434
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1