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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD YELLOW MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD YELLOW MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4037744
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2021
Event Type  malfunction  
Event Description
Solid, clear particle noticed in the chamber of cadd pump.
 
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Brand NameCADD YELLOW MEDICATION CASSETTE RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11462523
MDR Text Key239475943
Report NumberMW5099927
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4037744
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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