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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. ALARIS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MS3500-15
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 07/02/2021
Event Type  malfunction  
Event Description
Spike was dirty in closed packaging. Went to spike a bag and found a dark brown/red particle.
 
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Brand NameALARIS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key12287028
MDR Text Key265406303
Report Number12287028
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 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS3500-15
Device Catalogue NumberMS3500-15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/13/2021
Event Location Outpatient Treatment Facility
Date Report to Manufacturer08/06/2021
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? No
Type of Device Usage Unkown

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