MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX BLUE LINE ULTRA CLEANING BRUSH FOR INNER CANNULAE; TUBE, TRACHEOSTOMY

Model Number 100/855/000

Device Problem Connection Problem (2900)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/11/2015

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that user had been cleaning the tracheostomy tube with the listed brush when the brush head detached from the handle and fell into the patient's lung.The patient was hospitalized to remove the brush, but the first attempt was unsuccessful.Patient was then transferred to another hospital for removal of brush.No permanent adverse effects to patient reported.

Manufacturer Narrative

(b)(4) unused brushes were returned for evaluation.The samples were visually inspected.No defects or abormalities were detected on any of the returned samples.In an attempt to reproduce the reported detachment, the samples were pulled by hand.No detachment was observed in any of the samples.There was no evidence found to suggest the event was caused from intrinsic defect in the device.

• Brand Name: PORTEX BLUE LINE ULTRA CLEANING BRUSH FOR INNER CANNULAE
• Type of Device: TUBE, TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5117191
• MDR Text Key: 27222298
• Report Number: 2183502-2015-00725
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2019
• Device Model Number: 100/855/000
• Device Catalogue Number: 100/855/000
• Device Lot Number: 2762686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention