• 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 MEDICATION CASSETTES 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 MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problems Diarrhea (1811); Headache (1880); Pain (1994); Swelling/ Edema (4577)
Event Date 01/03/2022
Event Type  malfunction  
Event Description
Patient complained of diarrhea daily, first bite jaw pain, headache, complained of pain in right ankle but thinks is related to his (patient's) gout. Took indocin after i arrived, and it eased the pain, has 2+ pitting edema lower extremities (states is decreased from usual). It was reported that "when we changed the cartridge to the one that had been prepared yesterday, we discovered it was leaking. Upon inspection, we discovered fluid in the cartridge between the plastic shell and the bladder. ".
 
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. Lacking any additional evidence, this complaint has been closed as unconfirmed. If the product is returned, smiths medical will reopen this complaint for further investigation. A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD MEDICATION CASSETTES
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 Key14239984
MDR Text Key290386564
Report Number3012307300-2022-07068
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

-
-