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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 21-7336-24
Medical Device Problem Codes Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/14/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that a smiths medical cadd administration set broke in two where the line attaches to the 0.2micron air eliminating filter.The extension line separated from the proximal end of the filter.The issue occurred on the second day of the line being used for the administration blinatumomab continuous infusion.The patient went to the hospital and a pharmacist made a new bag of medication to be connected.There was no patient injury.
 
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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 Key11201774
Report Number3012307300-2021-00582
Device Sequence Number3727219
Product Code FPA
UDI-Device Identifier10610586027291
UDI-Public10610586027291
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/20/2021
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 Number21-7336-24
Device Catalogue Number21-7336-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2020
Initial Report FDA Received Date01/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age4 YR
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