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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.
 
Event Description
Additional information received and summarized in h 10.A correction on aware date is summarized in h 10 corrective data.
 
Manufacturer Narrative
Other, other text: h 10 information was received in a customer response stating "information about the exact location/quadrant on the abdomen is unknown.Prescription of antibiotics/other concomitant medication was not mentioned in the record.", corrected data: aware date was changed on cover page and updated as it was september 16th and not september 15th, 2020.
 
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Brand Name
CLEO
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10608499
MDR Text Key209234468
Report Number3012307300-2020-09978
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30610586028391
UDI-Public30610586028391
Combination Product (y/n)N
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
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 Lay User/Patient
Device Model Number21-7230-24
Device Lot Number3915726
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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