MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® UNCUFFED D.I.C.® TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 502060

Device Problem Crack (1135)

Patient Problem Discomfort (2330)

Event Type  malfunction  

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 portex® uncuffed d.I.C.® tracheostomy tube was cracked.The fault was noticed after the patient "felt different, irritated" and woke up several times at night.The tracheostomy tube had been in use for just under four weeks.No patient injury was reported.

• Brand Name: PORTEX® UNCUFFED D.I.C.® 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 NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6714725
• MDR Text Key: 80069372
• Report Number: 3012307300-2017-01489
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 10351688037176
• UDI-Public: 10351688037176
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K903730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 502060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1