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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 21-7231-24
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/05/2020
Event Type  malfunction  
Event Description
It was reported that the device needle resulted in a skin reaction at the puncture site. When removing the needles the next day, a part of the teflon tube was reportedly missing. According to the patient approximately 7 mm of the teflon tube remained in the body. Additionally, the user was able to palpate a foreign body at the infusion site. They presented to the emergency room to have the foreign part removed. The part of the tube that was removed was discarded. No patient injury or complications were reported in relation to this event.
 
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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 Key10594095
MDR Text Key208797261
Report Number3012307300-2020-09900
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 foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7231-24
Device Catalogue Number21-7231-24
Device Lot Number3648232
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 Received11/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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