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

Model Number	ZZ19CN80NSC155N
Medical Device Problem Codes	Crack (1135); Fungus in Device Environment (2316); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the flange of a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube, a crack was found.Mold was reported to be observed in the trach.The plastic ring was taken out and cleaned.However, it was reported that after the third time cleaning the ring, it was observed to become detached.There were no reported adverse effects.
Additional Manufacturer Narrative
One bivona tracheostomy tube was returned for analysis.A tear on the top of the neck flange near the center of the hub and the retaining ring was broken upon visual inspection.Review of the neck flange mold and parts in inventory did not identify any similar defects.Based on the evidence, the complaint was confirmed.The root cause is due to user interface as if attempting to remove the rotating or fixed connector could damage the tube.

• Brand Name: PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE
• 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: 9514300
• Report Number: 3012307300-2019-07449
• Device Sequence Number: 11296080
• Product Code: JOH
• UDI-Device Identifier: 15019517186932
• UDI-Public: 15019517186932
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• 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): 03/17/2020

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: Health Professional
• Device Model Number: ZZ19CN80NSC155N
• Device Catalogue Number: ZZ19CN80NSC155N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1