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

Catalog Number	ZT18EN80NSC134NZ
Medical Device Problem Codes	Defective Component (2292); Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot ds017807 for 2 units was released on 25-jun-2018 for distribution.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the dhr.
Event or Problem Description
It was initially reported that the bivona custom tube had pin holes in the cuff.The tube was never sterilized, and had no leak prior to placement.It was later reported by the patient's physician that there was a cartilage in the end user's trachea that was damaging the cuff.The physician submitted a new template for a device with a longer length shaft, so that the cuff was positioned past the cartilage when the device was in situ.No death or serious injury was reported in connection with this incident.

• Brand Name: BIVONA CUSTOM TUBES
• 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: 7703775
• Report Number: 3012307300-2018-02706
• Device Sequence Number: 1452573
• Product Code: JOH
• UDI-Device Identifier: 15019517153057
• UDI-Public: 15019517153057
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: 06/22/2023
• Device Catalogue Number: ZT18EN80NSC134NZ
• Device Lot Number: DS017807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1