MAUDE Adverse Event Report: FLEXICARE, INC. FLEXICARE PROVUE INTUBATION SYSTEM; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 038-990-080U

Device Problems Complete Blockage (1094); Unintended Collision (1429)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/22/2020

Event Type  Injury  

Event Description

Provue intubation system by flexicare.The size 8 tubing collapsed and obstructed the patients airway.Patient was intubated using the provue intubation system by flexicare size 8 tube.Once the video stylet was removed from the tube, the tube occluded the patients airway.The anesthesiologist had to perform various techniques including bagging the patient to get o2 sats back up.The patient was transported to icu where the interventionist put the fiberoptic bronchoscopy down the patients et tube and saw the occlusion from the collapsed et tube.He then removed the et tube and re-intubated with another et tube.He also ordered radiology and discovered bilateral pneumothorax and proceeded to have two chest tubes placed bilaterally.After 2 days the chest tubes were removed and the patient recovered.On further investigation it is noted that the provue size 8 tube is composed of softer material under the balloon area of the tube.This construction lead to a collapse of the inner lumen of the et tube under the balloon once the balloon is inflated and pressure is applied to the balloon e.G.Patient trachea when placed by anesthesia provider.The product has been pulled and quarantined, risk and safety officer notified, vendor notified, (b)(6), division cmo notified.

• Brand Name: FLEXICARE PROVUE INTUBATION SYSTEM
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): FLEXICARE, INC.; 15281 barranca pkwy unit d; irvine CA 92618
• MDR Report Key: 10206180
• MDR Text Key: 197145290
• Report Number: MW5095262
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/25/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 038-990-080U
• Device Catalogue Number: 038-990-0800U
• Device Lot Number: 200300539
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 41