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

Catalog Number 60SP050

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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
• 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6491305
• MDR Text Key: 72801778
• Report Number: 3012307300-2017-00856
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312000405
• UDI-Public: 15021312000405
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60SP050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: No
• 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