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

Catalog Number	ST18KN55NSC143N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a mother called in stating that the cuff was leaking of her childs smiths medical custom bivona flextend tts pediatric tube.No adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: one bivona tracheostomy tube was returned for investigation.A visual inspection under normal plant lighting did not reveal any defects.The device was then leak tested, and a slow leak was observed inside the tubing at the joint of the shaft tubing and neck flange.A slow leak in the device was confirmed.The investigation determined that the lumen wall near the inside diameter of the shaft had been pierced by the teflon tubing that connects the airway line to the lumen that is manufactured in the wall of the shaft.The investigation could not determine whether the teflon tube pierced the lumen during manufacturing or if unusual / excessive manipulation of the airway line in the field caused the lumen to be pierced.  .

• Brand Name: BIVONA CUSTOM FLEXTEND TTS PEDIATRIC 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: 9132757
• Report Number: 3012307300-2019-05219
• Device Sequence Number: 19629628
• Product Code: JOH
• UDI-Device Identifier: 15019517173321
• UDI-Public: 15019517173321
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: Lay User/Patient
• Device Expiration Date: 07/11/2024
• Device Catalogue Number: ST18KN55NSC143N
• Device Lot Number: DS028530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/29/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: Congenital Anomaly
• Patient Age: 16 YR