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

Catalog Number	ZP17JN40NSB080N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date is an approximate date.Only the month and year ((b)(6) 2018) are known.Evaluation results: two bivona devices were returned for investigation; one had the swivel connector painted blue (device 1) and the other device was returned unadulterated (device 2). visual inspection was performed with the unaided eye under normal plant lighting. no obvious defects were observed. using a syringe, 10 ml of air was inserted into the inflation valve of device 1. the cuff did not inflate and an air leak was heard.The leak was identified in the pilot balloon. using magnification, the leak area was inspected.The visual investigation performed under magnification did not identify any molding defects with the pilot balloon; it did however identify a cut immediately above where the airway line ends inside the pilot balloon.The pilot balloon either came in contact with a sharp object or the pilot balloon became trapped between two surfaces, which damaged the pilot balloon. the device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event, therefore no corrective actions are planned at this time.Next, air was inserted into the inflation valve of device 2  the cuff inflated.No leaks were observed.  .
Event or Problem Description
It was reported that the device inadvertently deflated after inflation.There were no clinical consequences to patient.

• Brand Name: BIVONA
• 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: 8856719
• Report Number: 3012307300-2019-03818
• Device Sequence Number: 2028129
• Product Code: JOH
• UDI-Device Identifier: 15019517127843
• UDI-Public: 15019517127843
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/02/2019

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 Catalogue Number: ZP17JN40NSB080N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 MO