• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FLEXICARE, INC. FLEXICARE PROVUE INTUBATION SYSTEM; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10206180
MDR Text Key197145290
Report NumberMW5095262
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Date10/01/2020
Device Model Number038-990-080U
Device Catalogue Number038-990-0800U
Device Lot Number200300539
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/26/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age66 YR
Patient Weight41
-
-