MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CUSTOM BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Catalog Number	ZT18HN65NSZ016N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the pilot balloon on a smiths medical custom bivona flextend tts tracheostomy tube broke off, a tube change out was required.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: updated age or date of birth,sex,weight,ethnicity,race.Device evaluation : two customized 6.5 flextend tts cuff aire cuff devices were returned with the airway inflation balloons completely detached from the airway line for evaluation.There was only one detached airway balloon returned.The presence of the airway line inside the balloon detected that the bond was sufficient in retaining the airway line within the balloon as the airway line broke outside the balloon.Additionally, the airway lines did not show any evidence of being stretched (exceeding tensile force), but it did appear to have been cut.The device instruction for use states under warnings to guard against product damage by avoiding contact with sharp edges.All device cuffs and balloons are 100% inspected and leak tested to prior to packaging.Based on the evidence and testing, the complaint was confirmed.However, the investigation did not reveal any intrinsic manufacturing defects with the returned devices and could not identify a specific problem source.

• Brand Name: CUSTOM BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE
• 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: 9188027
• Report Number: 3012307300-2019-05663
• Device Sequence Number: 3642879
• Product Code: JOH
• UDI-Device Identifier: 15019517161090
• UDI-Public: 15019517161090
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: Lay User/Patient
• Device Expiration Date: 05/08/2024
• Device Catalogue Number: ZT18HN65NSZ016N
• Device Lot Number: DS027044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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
• Patient Age: 16 YR
• Patient Weight: 40