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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
No product samples, images, or videos were returned for evaluation. The lot number was not provided, so a lot history review could not be completed. The complaint cannot be confirmed.
 
Event Description
The event occurred on an unspecified date involving a plumset that was reported to have white "condense" in the infusion set that they could not remove. There is no report of 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
MDR Report Key12622540
MDR Text Key276173876
Report Number9615050-2021-00147
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1468728
Device Catalogue Number146870489
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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