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

Catalog Number	CM3289NC
Medical Device Problem Codes	Crack (1135); Disconnection (1171)
Health Effect - Clinical Code	Suffocation (2088)
Date of Event	05/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received that the bivona trach tube was disconnected from the iso connector the iso connector detached from the rest of the cannula leaving no connection to the ventilator.A new cannula was inserted promptly to ventilate the patient.This incident occurred after approximately 11 months of use.No permanent damage reported.
Additional Manufacturer Narrative
One custom-made fixed tracheostomy tube with a fome-cuf stoma-seal was returned for analysis.Upon visual inspection the trach was confirmed to be broken and the plastic connector had been completely detached from the device to the retaining ring.The iso connector was also noted to be cracked and partially still attached which normally has adhesive holding the retaining ring to it.Based on the evidence, the iso connector was possibly forcibly removed from the device; causing the retaining ring to crack and the connector to disconnect from the device.The allegation was confirmed but the root cause is unknown.

• Brand Name: BIVONA CUSTOMIZED FIXED 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: 7767805
• Report Number: 3012307300-2018-03234
• Device Sequence Number: 1986111
• Product Code: JOH
• UDI-Device Identifier: 15019517080490
• UDI-Public: 15019517080490
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/08/2022
• Device Catalogue Number: CM3289NC
• Device Lot Number: DS005778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTERSURGICAL VENTILATOR
• Outcome Attributed to Adverse Event: Required Intervention