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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CLEO 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CLEO 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7220-24
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Abscess (1690)
Event Date 10/13/2019
Event Type  Injury  
Event Description
Information was received indicating that the adhesive pad to a smiths medical cleo 90 infusion set would not stick to the patient. Multiple attempts were done to get the device to stick to the patient. It was also reported that hospitalization occurred to manage the adhesive problem along with a right lower quadrant abdominal abscess. The patient received their medication with no further reported adverse effects.
 
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Brand NameCLEO 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10171428
MDR Text Key195659460
Report Number3012307300-2020-06068
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 06/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7220-24
Device Catalogue Number21-7220-24
Device Lot Number3677257
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/18/2020 Patient Sequence Number: 1
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