MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFSS35
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age : dob listed as (b)(6) 2016.Related mfr: 3012307300-2019-01988.
Event or Problem Description
Information was received that a smiths medical portex bivona flextend tts pediatric straight neck flange tracheostomy tube balloon would not inflate symmetrically.Issue was discovered while in use with a patient under care of home nursing.Subsequently, the nurse was able to use a "back- up" tracheostomy (trach) tube, and no patient harm occurred.
Additional Manufacturer Narrative
Two tracheostomy tubes were received for evaluation.Visual inspection found them to be in good physical condition.The devices underwent air cuff symetry testing, and it was observed the cuffs were not inflating symmetrically.When measuring the cuffs and their symmetry, the percentages for sample 1 was 43.24% and sample 2 was 47.36% , resulting in two cuffs within specification.The reported customer complaint was unable to be confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE 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: 8511645
• Report Number: 3012307300-2019-01987
• Device Sequence Number: 13933643
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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 Model Number: 67PFSS35
• Device Catalogue Number: 67PFSS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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: 3 YR