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

MAUDE Adverse Event Report: UNKNOWN SET ADMINISTRATION INTRAVASCULAR

  • 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
 

UNKNOWN SET ADMINISTRATION INTRAVASCULAR Back to Search Results
Device Problems Material Puncture/Hole (1504); Battery Problem (2885)
Patient Problem Dyspnea (1816)
Event Type  malfunction  
Event Description
Patient had iv line replaced on (b)(6) 2018. There was a hole in the patients line. Since the replacement patient has felt more short of breath. Patient will discuss with md at appointment on monday. Patient also reported pump (b)(4) seems to drain battery faster than other pump advised we will send replacement pump for delivery tomorrow to home. Solicited. No other information available. Reported to (b)(6) by: patient/caregiver. Strength: 1. 5mg. Dose or amount 9ng/kg/min, frequency: continuous, route: iv. Dates of use: from (b)(6) 2018 to current. Diagnosis or reason for use: pah.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSET ADMINISTRATION INTRAVASCULAR
Type of DeviceSET ADMINISTRATION INTRAVASCULAR
Manufacturer (Section D)
UNKNOWN
MDR Report Key8141979
MDR Text Key130028788
Report NumberMW5081917
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/20/2018
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

-
-