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

MAUDE Adverse Event Report: ICU MEDICAL MICRO CLAVE MALE PLUG, CSTD SET, ADMINISTRATION

  • 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
 

ICU MEDICAL MICRO CLAVE MALE PLUG, CSTD SET, ADMINISTRATION Back to Search Results
Catalog Number 20130-01
Device Problems Disconnection (1171); Fluid Leak (1250); Sticking (1597); Defective Component (2292)
Patient Problem No Information (3190)
Event Date 12/13/2017
Event Type  malfunction  
Event Description
"micro clave male plug, cstd closed system transfer device". When iv line disconnected from blue lumen of patient's triple lumen cvad, the inner part of micro clave male plug was found to be "stuck" in depressed position, and small amount of blood also noted to have migrated and inside end of iv tubing. Cap changed and defective cap saved for follow-up. Potential for injury with increased risk of line infection due to the malfunction. This is the second occurrence.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICRO CLAVE MALE PLUG, CSTD
Type of DeviceSET, ADMINISTRATION
Manufacturer (Section D)
ICU MEDICAL
san clemente CA 92673
MDR Report Key7154415
MDR Text Key96209518
Report NumberMW5074289
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
Type of Report Initial
Report Date 12/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number20130-01
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? No
Type of Device Usage

-
-