MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three bivona flextend¿ tts¿ tracheostomy tubes were returned for analysis.No damage was noted to the units upon visual examination.An air cuff symmetry test was performed finding that the all three cuff's inflated without problems.The cuffs were then measured; noting that all were within specification.Relevant documents were reviewed and deemed adequate.The manufacturing process was reviewed finding that all procedures were being carried out appropriate.Training was reviewed, confirming that the personnel had trainings up to date.Verification of (b)(4) assemblies were reviewed and deemed adequate.It was seen production personnel performs a 100% air cuff symmetry visual inspection during process and quality inspectors takes a representative sample of the lot and performs air cuff symmetry test.Based on the evidence, the complaint was not confirmed with no fault found.
Event or Problem Description
Information was received indicating that during a tracheostomy (trach) tube change out, a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube cuff would only partially inflate.It was reported the staff were attempting to change out and size up during this pediatric airway emergency.Two more trach tubes were attempted to be used during this emergency with the same.A different trach lot number was then used and placed.There were no reported adverse patient effects.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7947925
• Report Number: 3012307300-2018-04182
• Device Sequence Number: 2255295
• Product Code: JOH
• UDI-Device Identifier: 10351688518637
• UDI-Public: 10351688518637
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

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: No Information
• Device Expiration Date: 03/24/2022
• Device Catalogue Number: 67PFS45
• Device Lot Number: 3368127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/09/2018
• 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: Life Threatening