MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60PFS40
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun, as the device is currently in transit to the invesitgation site.
Event or Problem Description
It was reported that the loop of a bivona® uncuffed pediatric flextend¿ plus silicone tracheostomy tube seems to have split after using the tracheostomy tube three times.It was noted that it broke in the box, the patient's parent said it "popped".No injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation in used condition.Visual inspection found the device with 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 were performed and did not detect any damage on the units.Based on the evidence, the root cause was unable to be confirmed.It was suspected that the most probable root cause is related to damage once the device left the manufacturing facility.

• Brand Name: BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE
• 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: 6761464
• Report Number: 3012307300-2017-01666
• Device Sequence Number: 2014058
• Product Code: JOH
• UDI-Device Identifier: 15021312005868
• UDI-Public: 15021312005868
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083641
• 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): 04/19/2018

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: No Information
• Device Catalogue Number: 60PFS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 08/02/2017
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 4