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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. NEUTRON CAP SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. NEUTRON CAP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number NC100
Device Problem Reflux within Device (1522)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Event Description
When rn was drawing labs, neutron cap filled with blood. Labs were drawn with yellow stop cock, provided in labs kit. Rn promptly changed neutron cap. There was no detectable harm. The device was disposed of. Unsure of the device's lot number, might be lot # 5019395 or 5126619 (based on current stock on event date).
 
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Brand NameNEUTRON CAP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key11752144
MDR Text Key248186947
Report Number11752144
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNC100
Device Lot Number5019395 OR 5126619
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/23/2021
Event Location Hospital
Date Report to Manufacturer04/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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