MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® ADULT FOME-CUF® TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	855190
Medical Device Problem Codes	Deflation Problem (1149); Leak/Splash (1354)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pneumonia (2011)
Date of Event	01/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a leak was noted on a cannula to a smiths medical bivona® adult fome-cuf® tracheostomy tube.The cannula was changed out and the cuff to the tracheostomy (trach) deflated and re-inflated.Two days following, a bacterial infection (pneumonia) was reported and the cuff was deflated.The patient was required to be mechanically ventilated and treatment was ordered.The patient has recovered and the infection resolved.
Additional Manufacturer Narrative
One device was returned for evaluation.Visual inspection of the device revealed no defects.Leak testing was performed and did not found any evidence of cuff leakage.The cuff was also inflated beyond the fome surface and did not show any evidence of cuff leakage.A review of the device history record was performed and was found to be complete.Based on the evidence, a root cause was unable to be confirmed.No defect was detected with the returned device.

• Brand Name: BIVONA® ADULT FOME-CUF® TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7230934
• Report Number: 3012307300-2018-00175
• Device Sequence Number: 1890118
• Product Code: BTO
• UDI-Device Identifier: 15021312006926
• UDI-Public: 15021312006926
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K912469
• 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,Followup
• Report Date (Section B): 03/26/2018

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: Health Professional
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: 855190
• Device Lot Number: 3304758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 02/28/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/12/2018; 03/26/2018
• 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: 54 YR