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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Inaccurate Delivery (2339)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported the disposable is not infusing correctly.The patient advised that sometimes she feels that she has not been getting enough veletri medication through the line.Patient also reports that she can feel the effects of less flow, since she is now on a higher dose.No adverse patient effects were reported by the customer.
 
Manufacturer Narrative
No information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Manufacturer Narrative
Other text: no product was returned.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.D3, g1, g2 email address: regulatory.Responses@icumed.Com.
 
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Brand Name
CADD CASSETTE RESERVOIRS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17483720
MDR Text Key320768659
Report Number3012307300-2023-07905
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/23/2024
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
Patient Sequence Number1
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