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: COVIDIEN ENFIT CONNECTION SYSTEM
  • 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
 

COVIDIEN ENFIT CONNECTION SYSTEM Back to Search Results
Device Problems Complete Blockage (1094); Disconnection (1171); Leak/Splash (1354); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problems Bacterial Infection (1735); Flatus (1865); Unspecified Infection (1930); Malaise (2359)
Event Date 12/01/2015
Event Type  Injury  
Event Description
Patient called to report adverse events involving her enfit connection system for her j-tube.Patient stated she has had several problems with this device since she received it in (b)(6).Patient said she believes bacteria gets harbored in the connection device, causing her to get infections.Patient stated in the last five months, she has had three new feeding tubes, two staph infections, five bacterial infections, two hospital stays, two emergency room visits and two doctor visits.Patient said she had problems screwing on the connection system, it stays loose, it pulls apart, and leaks all over.She said she's experienced more problems with clogging and is bloated all the time and sick.She also stated that it's hard to operate and her feeding time takes three times longer than it used to.Patient said she is frustrated and disappointed with the way the device operates, and thinks it needs immediate review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENFIT CONNECTION SYSTEM
Type of Device
ENFIT CONNECTION SYSTEM
Manufacturer (Section D)
COVIDIEN
MDR Report Key5554248
MDR Text Key42205378
Report NumberMW5061542
Device Sequence Number1
Product Code PIF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Other Device ID NumberREF: 773656
Is the Reporter a Health Professional? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age62 YR
-
-