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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CLEO SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CLEO SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7230-24
Device Problem Contamination (1120)
Patient Problem Abscess (1690)
Event Date 07/27/2020
Event Type  malfunction  
Manufacturer Narrative
Customer facility phone: (b)(6).
 
Event Description
Information was received indicating that a smiths medical cleo administration set was implicated in a patient producing an abdominal abscess at the infusion site. There were no other adverse events reported.
 
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Brand NameCLEO
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10608499
MDR Text Key209234468
Report Number3012307300-2020-09978
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number21-7230-24
Device Lot Number3915726
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/30/2020 Patient Sequence Number: 1
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