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

Catalog Number	HT18ES70NSZ003N
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.One custom made tracheostomy tube was received for device evaluation.Visual inspection with the unaided eye did not reveal any discrepancies or anomalies.Functional testing was performed using a standard syringe to inflate the cuff with 15 ml water.The cuff slightly inflated, and a stream of water came from the cuff.Visual inspection using magnification found a small cut on the cuf, which appeared to have resulted from the device coming into contact with something sharp (i.E.Cartilage, cleaning implement, fingernail, etc.).Since this was not an out of box failure, it is unlikely that the cut occurred during the manufacturing process.The instruction for use states the following under warnings and cautions: "guard against product damage by avoiding contact with sharp edges.During reprocessing, aggressive scrubbing of the tube or use of hard bristled brushes or sharp wire mounted swabs may damage the surface of the tube".
Event or Problem Description
It was reported that during use of this custom made tracheostomy tube, a pin hole was observed at the cuff, and water began leaking.No adverse patient effects were reported.

• Brand Name: PORTEX® BIVONA® CUSTOM MADE 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: 7700298
• Report Number: 3012307300-2018-02845
• Device Sequence Number: 1452533
• Product Code: JOH
• UDI-Device Identifier: 15019517150933
• UDI-Public: 15019517150933
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 05/11/2023
• Device Catalogue Number: HT18ES70NSZ003N
• Device Lot Number: DS016200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1