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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 21-7052-24
Device Problem Connection Problem (2900)
Patient Problems Diarrhea (1811); Headache (1880)
Event Type  malfunction  
Event Description
Information was received indicating that the cadd extension set became disconnected from the cassette end.It was reported that the patient went without medications for several hours due to the malfunction.The patient felt unwell.Then had to endure side effects of sudden start of medication when reconnected (headache, flushing, diarrhea) which lasted in one of the cases for a couple of days.It was a significant contributor to patient anxiety.To continue therapy, the patient reattached and remade her medication as needed and symptoms resolved.
 
Manufacturer Narrative
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 Key11408747
MDR Text Key234614976
Report Number3012307300-2021-01733
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586020346
UDI-Public10610586020346
Combination Product (y/n)N
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7052-24
Device Lot Number4025966
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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