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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 21-7036-01
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/22/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a nurse primed an epidural tubing manually with an epidural bag, then noticed that fluid was leaking from the tubing.A cut/break was found on the product so another epidural tubing and epidural bag was opened, primed and used without a problem.The affected product was discarded.No patient injury or complications were reported in relation to this event.There was only a short delay in the procedure.
 
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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 Key10567976
Report Number3012307300-2020-09674
Device Sequence Number3581063
Product Code FPA
UDI-Device Identifier10610586020186
UDI-Public10610586020186
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K933390
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/22/2020
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 Health Professional
Device Model Number21-7036-01
Device Catalogue Number21-7036-01
Device Lot NumberUNKNOWN
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 09/03/2020
Initial Report FDA Received Date09/22/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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