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

MAUDE Adverse Event Report: IV ADMINISTRATION 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
 

IV ADMINISTRATION SET Back to Search Results
Device Problems Break (1069); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Patient Problems Missed Dose (2561); Foreign Body In Patient (2687)
Event Date 09/18/2018
Event Type  Injury  
Event Description
Pt reported that he sometimes forgets to take his morning dose of symdeko (possibly missed a couple of doses recently). Advised him regarding the 6-hour missed dose window and to download a medication adherence application for his phone or set alarms as reminders to take his doses. He was also hospitalized a couple of months ago due to an iv port breaking off, and the catheter portion migrating to his liver which drs were able to remove. Dates of use: (b)(6) 2018 - present.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameIV ADMINISTRATION SET
Type of DeviceIV ADMINISTRATION SET
MDR Report Key7914650
MDR Text Key122147165
Report NumberMW5080177
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 09/26/2018 Patient Sequence Number: 1
-
-