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U.S. Department of Health and Human Services

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

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ST PAUL CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7322-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
Other, other text: investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available.
 
Event Description
It was reported that the patient's device did not infuse their medication. No patient injury was reported.
 
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Brand NameCADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW
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
suite 10
minneapolis, MN 55442
MDR Report Key15233807
MDR Text Key297977733
Report Number3012307300-2022-15416
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586029646
UDI-Public10610586029646
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 User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7322-24
Device Catalogue Number21-7322-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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