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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 21-7383-24
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/09/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer contact phone number: (b)(6).Device evaluation in progress.
 
Event or Problem Description
It was reported that liquid was found on the bottom of the backpack, although the puncture needle was set correctly into the infusion port.No patient injury or complications were reported in relation to this event.
 
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Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11790521
Report Number3012307300-2021-04016
Device Sequence Number4381181
Product Code FPA
UDI-Device Identifier10610586027475
UDI-Public10610586027475
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date05/19/2025
Device Model Number21-7383-24
Device Catalogue Number21-7383-24
Device Lot Number3971522
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2021
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date05/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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