Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; INTRAVENOUS EXTENSION TUBING SET
  • 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
 

; INTRAVENOUS EXTENSION TUBING SET Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2020
Event Type  malfunction  
Event Description
Patient's mom called out when she noted something was wet under iv tubing.Iv tubing became disconnected between filter and trifuse.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
INTRAVENOUS EXTENSION TUBING SET
MDR Report Key9646631
MDR Text Key176960391
Report Number9646631
Device Sequence Number1
Product Code OJA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/23/2020
Event Location Hospital
Date Report to Manufacturer01/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-