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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7383-24
Medical Device Problem Code Restricted Flow rate (1248)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/05/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device was being primed and required 10 ml of fluid rather than the expected 8 ml.The reporter stated the set primed more slowly than usual.No adverse effects reported.
 
Additional Manufacturer Narrative
Additional information received on 4-jan-2021: it was reported that to resolve the reported issue, the user changed the tubing.
 
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Brand Name
CADD ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11058493
Report Number3012307300-2020-12677
Device Sequence Number2683832
Product Code FPA
UDI-Device Identifier10610586027475
UDI-Public10610586027475
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date (Section B) 02/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number21-7383-24
Device Catalogue Number21-7383-24
Device Lot Number3957638
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/27/2020
Supplement Date Received by Manufacturer01/04/2021
Initial Report FDA Received Date12/22/2020
Supplement Report FDA Received Date02/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age26 YR
Patient Weight65
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