MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60P050
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tracheostomy tube is for single patient use, but can be used multiple times on the same patient.
Event or Problem Description
It was reported that the tube was torn off when the patient was moving about while using a bivona® uncuffed pediatric tracheostomy tube.There were no patient adverse events.
Additional Manufacturer Narrative
One device was returned for evaluation without its original packaging.Visual inspection of the device found a split on the flange eyelet.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.A review of 32 assemblies on the line was performed for molding issues and did not detect any damage.An attempt to reproduce the failure mode was performed by making a small cut on the inside and outside and pulled with a twill tape cut.Based on the evidence, a root cause was unable to be confirmed.It was determined that the most probable root cause is that damaged occurred after the device left the manufacturing facility.

• Brand Name: BIVONA® UNCUFFED PEDIATRIC 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: 7042605
• Report Number: 3012307300-2017-02421
• Device Sequence Number: 1423928
• Product Code: BTO
• UDI-Device Identifier: 15021312005776
• UDI-Public: 15021312005776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/12/2018

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: Patient Family Member or Friend
• Device Catalogue Number: 60P050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1