MAUDE Adverse Event Report: SMITHS MEDICAL PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE

Catalog Number 100/523/080

Device Problem Fracture (1260)

Patient Problems Hypoxia (1918); Shock, Traumatic (2268); Extubate (2402)

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Distributor reported on behalf of user facility that the device was in use with a patient in icu.According to treating anesthesiologist, a leaking sound was heard from the tube.Anesthesiologist inflated the product cuff with more air.However, later during transport of patient, the leaking sound occurred again and the tube was found to have split and an emergency tube change was required.According to reporter, the patient was reintubated after some difficulty.No permanent adverse effects reported.

Manufacturer Narrative

A used tracheostomy tube was returned for evaluation.The device was received inside a plastic bag without the original packaging.A review of the device history review showed no deviations or abnormalities related to the reported issue.The device was visually inspected; this showed a break on the connector with white stress marks present on the material.When this device is manufactured, the devices are 100% visually inspected prior to packaging.If the damage on the returned sample had been present during manufacturing, this issue would have been visually detectable during inspection.No evidence was found to suggest that the break on the connector was due to an intrinsic device issue.Device return date (12/10/2015).Device evaluation completion date (07/28/2016).

• Brand Name: PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5274265
• MDR Text Key: 32926636
• Report Number: 2183502-2015-00956
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: 100/523/080
• Device Lot Number: 2623215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention