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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD

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ST PAUL CADD Back to Search Results
Model Number 21-7336-24
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration set - flow stop was broken by the air filter. There were no adverse events reported.
 
Event Description
Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop.
 
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Brand NameCADD
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
valdemar hansens vej 1-23, 260
minneapolis, MN 55442
MDR Report Key10161052
MDR Text Key195361431
Report Number3012307300-2020-05999
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7336-24
Device Lot Number3931548
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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