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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM BURETTE CLAVE SITES 114IN NDEHP SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL COSTA RICA LTD. PLUM BURETTE CLAVE SITES 114IN NDEHP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1427329
Device Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2020
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned; however it has not yet been received.
 
Event Description
The event involved a plumset that was reported to have a small amount of taxotere leakage on the bottom burette during infusion. The healthcare provider immediately stopped infusion and changed to another plumset. There was patient involvement and no harm reported.
 
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Brand NamePLUM BURETTE CLAVE SITES 114IN NDEHP
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 Key11096168
MDR Text Key225303079
Report Number9615050-2020-00280
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
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1427329
Device Catalogue Number142730490
Device Lot Number4737028
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 Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
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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