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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STO SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STO 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 Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing. The product was returned and visual testing was performed no damages were detected on the samples. The reported issue could not be determined since the complaint was not confirmed due to the fact the accuracy test was successfully passed.
 
Event Description
It was reported that the patient noticed the pumping tube on the pressure plate was misaligned. No patient injury was reported.
 
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Brand NameCADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STO
Type of DeviceSET, 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
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key14326781
MDR Text Key291394923
Report Number3012307300-2022-08074
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
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 Number3834165
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0148-2022

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