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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 21-7323-24
Device Problems Insufficient Flow or Under Infusion (2182); Priming Problem (4040)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration sets - flow stop experienced a malfunction.It was reported that when using the administration set there was difficulty experienced during priming the pump and there was also issues with under delivery.The issue occurred during testing.
 
Manufacturer Narrative
40 cadd administration sets was returned for evaluation of failed accuracy testing.A device history review, dhr, was performed and no problems or issues were identified.A functional testing was performed to investigate the reported issue and the reported issue was able to be confirmed.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is was noted to be manufacturing.
 
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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
MDR Report Key10488397
MDR Text Key205506508
Report Number3012307300-2020-09024
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586039614
UDI-Public10610586039614
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 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7323-24
Device Lot Number3910176
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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