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

MAUDE Adverse Event Report: SMITHS MEDICAL PROTECT IVPLUS SAFETY IVCATHETER - RADIOPAQUE #20 IV CATHETER

  • 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
 

SMITHS MEDICAL PROTECT IVPLUS SAFETY IVCATHETER - RADIOPAQUE #20 IV CATHETER Back to Search Results
Device Problems Break (1069); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/01/2017
Event Type  Injury  
Event Description
Smiths medical jelco 20g x 1 1/4" protect lv plus broke away from hub and traveled into patient's lung. Iv was inserted in right wrist. On day 2, patient found with iv hanging from wrist attached only by a small piece of tape. Plastic catheter was missing from the hub of iv. Ultrasound was done showing fibrin tissue in forearm. Ct chest revealed catheter in rul lung. Iv inserted (b)(6). Catheter discovered to be disconnected from hub (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROTECT IVPLUS SAFETY IVCATHETER - RADIOPAQUE
Type of Device#20 IV CATHETER
Manufacturer (Section D)
SMITHS MEDICAL
southington CT 06489
MDR Report Key6610479
MDR Text Key76741671
Report NumberMW5070157
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/01/2017 Patient Sequence Number: 1
-
-