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

Catalog Number	ZT18BN65NSC102N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the swivel part of bivona tubes custom was broken.A replacement device was urgently requested.It was further reported that the patient was in the hospital since (b)(6), and that the aforementioned issue "has slowed his therapy therefore slowing his relief." no further complications were reported in connection with this event.

• Brand Name: BIVONA TUBES CUSTOM
• 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: 7611388
• Report Number: 3012307300-2018-02428
• Device Sequence Number: 19343965
• Product Code: JOH
• UDI-Device Identifier: 15019517142259
• UDI-Public: 15019517142259
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: No Information
• Device Catalogue Number: ZT18BN65NSC102N
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1