MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ST19EN55NGG996N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that following 24 hours after placement of a smiths medical portex® bivona customized tracheostomy (trach) tube the cuff was not holding water.The line that attaches to the cuff was reported to be leaking.Subsequently, a trach tube change out was performed.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Device underwent leak testing, confirming reported customer complaint.Markings were noted on the exterior airway at the point of the leakage.It was reported that the customer "used their teeth" to stabalize , which led to them "biting through the pilot balloon".Presumably, the markings on the tubing are from the customer's teeth.Upon inflating and deflating the tube, no discrepencies were noted with the valve; no seperation.This part of the customer's complaint has not been confirmed.The problem source cannot be defintively determined.However it is highly likey due to user interface.The directions for use advise to avoid contact with the product from sharp edges.

• Brand Name: PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 8894307
• Report Number: 3012307300-2019-04187
• Device Sequence Number: 372013
• Product Code: JOH
• UDI-Device Identifier: 15019517190663
• UDI-Public: 15019517190663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2024
• Device Catalogue Number: ST19EN55NGG996N
• Device Lot Number: SS021581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 09/29/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR