Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7062-24
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/27/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that during the use of a smiths medical cadd extension set, the customer noticed medical fluid was leaking from the connection part.There was no patient injury.
 
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11120995
Report Number3012307300-2020-12859
Device Sequence Number4050642
Product Code FPA
UDI-Device Identifier10610586020452
UDI-Public10610586020452
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K942046
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/30/2021
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 No Information
Device Model Number21-7062-24
Device Catalogue Number21-7062-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/04/2020
Supplement Date Received by Manufacturer03/31/2021
Initial Report FDA Received Date01/05/2021
Supplement Report FDA Received Date04/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-