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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Event Description
Information was received indicating that when filling the smiths medical cadd cassette reservoir, the bag has been breaking in the cassette, leaking the medication.It was reported that a syringe attached at the end was used to add drug and it started to leak out of the cassette.No patient consequences were reported.No adverse effects were reported.
 
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Brand Name
CADD
Type of Device
SET, 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 Key11094829
MDR Text Key224296663
Report Number3012307300-2020-12847
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4046848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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