MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFS50
Medical Device Problem Codes	Leak/Splash (1354); Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the patient is a "young child".The exact age is unknown.Pma 510(k): additional 510(k) - k083641.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 the silicone on a portex bivona uncuffed pediatric flextend plus silicone tracheostomy tube split at the top of the shaft, and the coil wire was exposed.The tracheostomy tube was in use when a staff member heard an audible leak and the ventilator alarmed.The tracheostomy tube was removed and a new one was placed immediately.It was after removal that the split in the silicone was observed.It was noted that the tracheostomy tube had "only been used twice".No injury was reported.

• Brand Name: PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6697687
• Report Number: 3012307300-2017-01443
• Device Sequence Number: 19080712
• Product Code: JOH
• UDI-Device Identifier: 15021312005882
• UDI-Public: 15021312005882
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: No Information
• Device Expiration Date: 10/21/2020
• Device Catalogue Number: 60PFS50
• Device Lot Number: 3051837
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 07/10/2017
• Supplement Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 11