MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRACHEOSTOMY SILICONE - BIVONA TUBES ; TUBE TRACHEOSTOMY AND TUBE CUFF, PRODUCT CODE: JOH

Model Number	SU15HN55NSA145N
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: a customized bivona uncuffed tracheostomy tube was received.Visual inspection did not reveal any manufacturing defects except that it was missing the removable swivel ring.The returned device was not broken or damaged.The device as returned would provide direct airway access to a tracheotomized patient.The swivel ring is designed to be removed.Since the swivel ring was not returned for examination, a review of the incoming inspection records for the swivel ring confirmed that the swivel ring met manufacturing specification.There were no non-conforming reports (ncrs) initiated for the lot ds018781 or anomalies identified in the dhr.Since the investigation did not identify a manufacturing defect with the returned device or its missing component, it is likely that the breakage was due to interaction among the device, hme, and caregiver.The complaint allegation, the device being broken or damaged, was not confirmed.
Event or Problem Description
Information was received that while in use a smiths medical tracheostomy silicone bivona tube "broke at the neck when they attached an hme"."traced the hme on trach tube and gets stuck.They broke it while attempting to remove it." of an unknown brand.Subsequently, a tracheostomy tube change out was performed.No adverse patient effects were reported.

• Brand Name: TRACHEOSTOMY SILICONE - BIVONA TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF, PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8392070
• Report Number: 3012307300-2019-01169
• Device Sequence Number: 1651556
• Product Code: JOH
• UDI-Device Identifier: 15019517142358
• UDI-Public: 15019517142358
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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: 08/08/2023
• Device Model Number: SU15HN55NSA145N
• Device Catalogue Number: SU15HN55NSA145N
• Device Lot Number: DS018781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/05/2019
• 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: Required Intervention