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 Unintended Movement (3026)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.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 during movement of the patient, a portex® uniperc® adjustable flange extended-length tracheostomy tube moved out of the trachea.The patient required resuscitation, and eventually expired.Additional information regarding the event was requested, however, the reporter stated that no further information was available.

• 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: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6641101
• MDR Text Key: 77561977
• Report Number: 3012307300-2017-01260
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315060441
• UDI-Public: 15019315060441
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/897/080
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death