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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
No product or photographic evidence were provided to aid in this investigation. The complaint report offered insufficient details to determine whether this product functioned as intended or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.
 
Event Description
Per medwatch form mw5106683, it was reported that cadd administration set had unknown issue. No patient injury reported.
 
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Brand NameCADD ADMINISTRATION SET WITH FLOW STOP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13759575
MDR Text Key287134840
Report Number3012307300-2022-04513
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4163625
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes

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