• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST PAUL CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7394-24
Device Problems Inadequacy of Device Shape and/or Size (1583); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT
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 Key15210342
Report Number3012307300-2022-15220
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7394-24
Device Lot Number4234955
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-