MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/897/080

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported that a portex® uniperc® adjustable flange extended-length tracheostomy tube connector came out while a patient was connected to a ventilator.The connector portion was found on the edge of the ventilator and had been "dislodged." the patient had the tracheostomy tube surgically inserted and the tube was checked preoperatively.The reporter was unsure when the connector initially came out: it was initially reported that the liaison nurse noted the connector and tracheostomy tube disconnect on (b)(6) 2016 but then it was noted to be disconnected on (b)(6) 2016 and fitted back in.The patient had intermittent periods off the ventilator per a weaning plan.No patient injury was reported.

Manufacturer Narrative

One used uniperc® adjustable flange extended-length tracheostomy tube was returned for investigation.The device was received inside a plastic bag and without its original packaging.Visual inspection revealed that the white connector of the device was detached from the tracheostomy tube.Additionally, it was noted that the connector showed signs of inadequate handling such as dents/scratches.Investigation determined that the root cause of the connector issue was due to the use of the device in a manner inconsistent from the instructions for use.

• Brand Name: PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; unit 4 bradwood court st.; 1 crispin way; rossendale, BB4 4 PW; UK BB4 4PW
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6012298
• MDR Text Key: 56965715
• Report Number: 3012307300-2016-00008
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 100