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

Catalog Number	ZT18BN65NSC102NZ
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	Serious Injury
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.
Additional Manufacturer Narrative
One custom tracheostomy tube was received for device evaluation.A review of the device history record could not be performed, as the lot number was not provided.Dimensional measurements were taken of the returned swivel connector.All measurements met manufacturing specification.The observed issue may have occurred due to user interface.The device instructions for use warn: the 4.5 care must be taken to avoid excessive force when connecting a circuit to this product.Failure to do so may result in difficulty disconnecting the circuit for emergency airway access for suctioning.The 4.6 always hold the base of the 15mm connector when disconnecting.If difficulty is experienced when disconnecting, utilize the disconnect wedge provided by inserting the thin end between the connectors and pushing to force them apart; refer to illustration a.Do not apply forces to the tube itself as this may result in tube damage which may compromise the airway.The 4.7 avoid excessive motion when attached to the ventilator as this may compromise the tube which may result in inadequate ventilation.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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: 7611403
• Report Number: 3012307300-2018-02427
• Device Sequence Number: 11029069
• 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,Followup
• Report Date (Section B): 07/27/2018

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: ZT18BN65NSC102NZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/27/2018
• 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: Hospitalization