MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS STRAIGHT NECK FLANGE TRACHEOSTOMY TUB; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	60PFS55
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: foreign country: (b)(6).
Event or Problem Description
Information was received that during a routine trach tie change, the flange on a smiths medical bivona uncuffed pediatric flextend plus straight neck flange tracheostomy tube was found to be broken.A trach change was done to resolve the issue.No adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: one bivona flextend plus tracheostomy tube was returned for investigation in used condition.Visual inspection was performed at 12 inches and under normal conditions of illumination so as to look for any damages to the parts.The visual inspection revealed that the tracheostomy tube was torn.There were splits in the neck strap.The visual inspection confirmed the customer reported product problem.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.The problem source of the reported product problem was unknown.A root cause was not established.

• Brand Name: BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS STRAIGHT NECK FLANGE TRACHEOSTOMY TUB
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9767260
• Report Number: 3012307300-2020-01549
• Device Sequence Number: 2216394
• Product Code: JOH
• UDI-Device Identifier: 15021312005899
• UDI-Public: 15021312005899
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 09/03/2022
• Device Model Number: 60PFS55
• Device Catalogue Number: 60PFSS35
• Device Lot Number: 3493977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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