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: CARDINAL HEALTH, INC. MONOJECT; SYRINGE, PISTON
  • 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
 

CARDINAL HEALTH, INC. MONOJECT; SYRINGE, PISTON Back to Search Results
Model Number 1186000777
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 11/05/2020
Event Type  malfunction  
Event Description
Shortly after change of shift it was noted that the lipids line was wet.Tracing back up to the spot where the syringe was screwed into the line's hub there was a large amount of leakage.End of syringe was broken.Lipids were stopped and disconnected from patient.Nurse practitioner was made aware.Pharmacy was contacted.After checking in with the pharmacy again they stated that it was all prepared under a hood to maintain sterility so the whole set up (tpn, total parenteral nutrition, included) would need to be redone.Nurse practitioner made aware, stated that patient could go without lipids infusing for the night.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MONOJECT
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
CARDINAL HEALTH, INC.
1222 sherwood rd
norfolk NE 68701
MDR Report Key11321032
MDR Text Key231588572
Report Number11321032
Device Sequence Number1
Product Code FMF
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1186000777
Device Catalogue Number1186000777
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/05/2021
Event Location Hospital
Date Report to Manufacturer02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age2 DA
Patient Weight3
-
-