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

Model Number	67PFS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Cyanosis (1798); Respiratory Distress (2045); Diaphoresis (2452); Pallor (2468); Low Oxygen Saturation (2477)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube was noted to be stained orange on the inside and that the cuff needed re-inflating.It was reported that when the patient cried, unusual sounds came from the trach area and that 2mls of water was required to re-inflate the cuff; as the water that was initially in the cuff had gone into the patient's lungs.The physician was notified, and the patient showed signs of respiratory distress, pallor, sweating, cyanosis, unconscious and o2 saturation below 50%.Subsequently, an emergent trach tube change out was performed and the ventilator was reconnected, the patient woke and o2 saturation rebounded.It was reported that the cuff to the old tube was found to be asymmetrical upon visually inspecting.The customer noted that the asymmetry of the cuff allowed food to pass the wrong way causing tube discoloration.There were no further reported adverse effects.
Additional Manufacturer Narrative
Device evaluation: returned device was received in good physical condition.During the evaluation of the device, when inflating the samples with air: three units inflated without problems and one inflated but all air was stuck in in the pilot balloon.According to the ifu (10018859-001 rev.100 - instruction for use - bivona tts flextend tracheostomy) the balloon was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.The customer reported condition was not confirmed.No fault found 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.

• 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
• MDR Report Key: 9814090
• Report Number: 3012307300-2020-01904
• Device Sequence Number: 13778040
• Product Code: JOH
• UDI-Device Identifier: 10351688518606
• UDI-Public: 10351688518606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 67PFS30
• Device Catalogue Number: 67PFS30
• Device Lot Number: 3840089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/05/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 06/29/2020
• 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: Life Threatening; Required Intervention