Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 CASSETTE RESERVOIR; 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 CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7309-24
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Event Description
Information was received indicating two cadd cassette reservoirs were occluded when taken out of the packaging and a third cassette had the same issue and was still in the packaging.No patient involvement.
 
Manufacturer Narrative
Report source: (b)(6).
 
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received indicating two cadd cassette reservoirs were occluded when taken out of the packaging and a third cassette had the same issue and was still in the packaging.No patient involvement.
 
Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: the report was submitted in error., corrected data: corrected information provided in h10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD MEDICATION CASSETTE RESERVOIR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13580218
MDR Text Key286023093
Report Number3012307300-2022-03851
Device Sequence Number1
Product Code FPA
UDI-Device Identifier30610586032381
UDI-Public30610586032381
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K081156
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number21-7309-24
Device Lot Number4183633
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-