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: CLEARLINK LUER ACTIVATED VALVE; 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
 

CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N8399
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported an unspecified quantity of clearlink luer activated valves leaked.It was further reported during ct/mri the ivs are having "blow outs".The events occurred during "high pressure contrast studies".It was further reported the clearlink luer activated valves are not recommended with high contrast injections.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLEARLINK LUER ACTIVATED VALVE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12548478
Report Number1416980-2021-05998
Device Sequence Number1100680
Product Code FPA
UDI-Device Identifier00085412048895
UDI-Public(01)00085412048895
Combination Product (Y/N)Y
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K112893
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number2N8399
Device Lot NumberSR21C15119
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/02/2021
Supplement Date Received by Manufacturer10/19/2021
Initial Report FDA Received Date09/29/2021
Supplement Report FDA Received Date10/28/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CONTRAST; CONTRAST
-
-