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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7323-24
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2021
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration sets - flow stop might have contributed to causing an infusion issue and a high-pressure error.It was also reported that when the tubing is used without the anti-siphon valve it works fine.The patient did not receive the entire amount of chemotherapy due to this issue, but there were no adverse events reported.When the tubing was changed, medication was administered and completed as intended.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11407741
MDR Text Key234614659
Report Number3012307300-2021-01713
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586039614
UDI-Public10610586039614
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number21-7323-24
Device Lot Number4066501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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