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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); Improper Flow or Infusion (2954)
Patient Problem No Information (3190)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
It was reported that a customer found residual volume of 35 mls was left in the 250 ml bag after using a smiths medical admin set.The pump stated 248.3 mls infused from 250 ml bag.No adverse patient effects were reported.
 
Manufacturer Narrative
Other, 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
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11156193
MDR Text Key226308654
Report Number3012307300-2021-00296
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
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 Received01/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7323-24
Device Catalogue Number21-7323-24
Device Lot Number3939042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
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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