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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1468728
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/06/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not been received.
 
Event Description
The event involved a plum set where a hole was found on the tubing which resulted in a leak, 10 minutes after infusion of nicardipine, for high blood pressure treatment. There was no unprotected exposure to the drug leak. There was patient involvement but no patient harm. No additional information was provided.
 
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Brand NameNDEHP PLUMSET 2CLAVES-SL
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key12550314
MDR Text Key274075660
Report Number9615050-2021-00138
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1468728
Device Catalogue Number146870489
Device Lot Number5192799
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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