MAUDE Adverse Event Report: SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/897/080

Device Problems Detachment Of Device Component (1104); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2015

Event Type  malfunction  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was reported that during use the moulded joint between the universal adaptor and the inner fixed white tube slipped out.Tracheostomy tube replacement was required.No adverse health outcome resulted from this event.

Manufacturer Narrative

One used sample was received for investigation.The device examination confirmed that the connector was disconnected from the tube.The examination also showed that a portion of the molded tube was missing (inflation line holder).The physical characteristics of the returned device (connector broken off and inflation line holder) were determined consistent with excessive force having been applied to the connector during use.The device instructions for use include the warning: "during and after attachment of the breathing system to the tracheostomy tube connector, avoid application of excessive rotational or linear forces on the tube to prevent accidental disconnection or occlusion.".

• Brand Name: UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 5388884
• MDR Text Key: 36773809
• Report Number: 2183502-2016-00093
• 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: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2016
• Was Device Evaluated by Manufacturer?: No
• 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