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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; INTRAVASCULAR ADMINISTRATION SET
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ST PAUL CADD; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-7302-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 01/24/2021
Event Type  malfunction  
Event Description
Information was received regarding a cadd cassette reservoir.It was reported that there was leakage in the inner bag.Liquid escaped through the housing and ran into the secondary pe-plastic packaging.This is a repeated issue.It is unknown if there was a patient involved.
 
Manufacturer Narrative
Other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11369719
MDR Text Key233241168
Report Number3012307300-2021-01489
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4037752
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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