MAUDE Adverse Event Report: SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES

Catalog Number 100/897/080

Device Problems Leak/Splash (1354); Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2015

Event Type  malfunction  

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

It was reported that the point at which the pilot balloon tubing joined the tracheostomy tube became worn away by the locking mechanism which led to a slow leak.Tracheostomy change was performed without issue.No adverse health outcome resulted from this event.

Manufacturer Narrative

The suspect tracheostomy tube was returned without its packaging for product inspection.Visual inspection observed no abnormalities or non-conformities.During functional testing, the cuff was inflated with air and the device submerged in water.No bubbles, suggesting a leak, were observed coming from the device.The tracheostomy tube, with pressurized cuff, was then left to rest for 12 hours.After the 12 hours, the device was inspected.No cuff reduction was observed; the cuff remained fully pressurized.The reported product issue could not be duplicated during product evaluation.As the returned product was confirmed to operate as intended, the reported product fault could not be confirmed.No corrective actions are planned at this time.

• Brand Name: UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBES
• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL; boundary road; hythe, kent CT216 JL; UK CT216JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, CT21 6JL; UK CT21 6JL
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5390586
• MDR Text Key: 36820900
• Report Number: 2183502-2016-00094
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/080
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1