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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2020
Event Type  malfunction  
Event Description
Information was received indicating that during the use of a smiths medical cadd cassette reservoir, the customer noticed medical fluid was leaking from the medication bag.There was no patient injury.
 
Manufacturer Narrative
Additional information: two pictures of smiths medical cadd cassette reservoir were returned for analysis and leak observed between the bag and the pump tube.Device evaluation: one smiths medical cadd cassette reservoir was returned for analysis.Leak testing was performed using a syringe to look for unusual functions and it was noted that the sample leaked between the bag and pump tube.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.
 
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Brand Name
CADD CASSETTE RESERVOIR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11090670
MDR Text Key224246970
Report Number3012307300-2020-12827
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 company representative,foreig
Type of Report Initial,Followup
Report Date 03/01/2021
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
Device Operator No Information
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number3983329
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/04/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received01/31/2021
Supplement Dates FDA Received03/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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