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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDHP 0.2 MICRN HP CL; SET, ADMINISTRATION, INTRAVASCULAR
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ICU MEDICAL COSTA RICA LTD. NDHP 0.2 MICRN HP CL; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2066828
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2022
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
 
Event Description
The event occurred on an unspecified date and involved a ndhp 0.2 micrn hp cl.The customer reported product failures with leaking chemo drugs at the filter.There was no report of harm.
 
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Brand Name
NDHP 0.2 MICRN HP CL
Type of Device
SET, 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 Key15328377
MDR Text Key303808294
Report Number9615050-2022-00188
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10887787005919
UDI-Public(01)10887787005919(17)241101(10)5633749
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2066828
Device Catalogue Number206680428
Device Lot Number5633749
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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