MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60SP050
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
It was reported that a portex® bivona® uncuffed neonatal and pediatric tracheostomy tube had its "'ears' where you put the tape for fixation torn".The eyelets were torn after 5 days of device use.The device was replaced with a new one.No patient injury was reported.
Additional Manufacturer Narrative
One used portex® bivona® uncuffed pediatric tracheostomy tube was returned for investigation.A visual inspection was performed and a split was observed on the flange eyelets.The most probable root cause was determined to be that the eyelet was damaged during use by coming into contact with a sharp edge, or the neck flange had a shot or a cut and it wasn't detected during the assembly process.The complaint was confirmed.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6491305
• Report Number: 3012307300-2017-00856
• Device Sequence Number: 19071077
• Product Code: BTO
• UDI-Device Identifier: 15021312000405
• UDI-Public: 15021312000405
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60SP050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1