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

Model Number	67SN030
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device was placed in use with patient but did not fully inflate on both sides of the cuff.The device was removed and replaced to continue ventilation.No further adverse effects reported.
Additional Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device when the sample was inflated with air, the pilot balloon inflated but all air was stuck it.According to the ifu (10018853-001 rev.100 - ifu - pedi/neo tts (pnt)) we manipulated the pilot balloon and the cuff inflated but only one side, we manipulated the cuff and the whole cuff inflated.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely.The customer reported condition was not confirmed.No fault found.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.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10797728
• Report Number: 3012307300-2020-11068
• Device Sequence Number: 14173533
• Product Code: JOH
• UDI-Device Identifier: 15021312000245
• UDI-Public: 15021312000245
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

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: Health Professional
• Device Model Number: 67SN030
• Device Catalogue Number: 67SN030
• Device Lot Number: 3585070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/29/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Weight: 4