MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 65P050

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

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.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Additional 510k number - k083641.

Event Description

It was reported that during patient use of the bivona® aire-cuf® neonatal and pediatric tracheostomy tube, the device cuff had an air leak and was unable to remain inflated.The tracheostomy tube was replaced after the reported issue was observed.It is unknown how long the device was in patient use before the incident was observed.The device cuff patency was tested prior to patient use.The event was considered resolved.No permanent injury was reported.

Manufacturer Narrative

One bivona® 5.0 mm aire-cuf® neonatal and pediatric tracheostomy tube was returned for investigation.Visual inspection revealed no defects or abnormalities with the returned device.During functional testing, the device cuff was inflated with air and the device was submerged under water.No bubbles (indicating a leak) were observed escaping from the device.Investigation was unable to confirm the reported event and found that the device functioned as intended.

• Brand Name: PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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, b.c 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6523370
• MDR Text Key: 74149512
• Report Number: 3012307300-2017-00898
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312005998
• UDI-Public: 15021312005998
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K944178
• 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: 05/24/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 65P050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• 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