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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 21-7109-24
Medical Device Problem Code Connection Problem (2900)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/11/2021
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that the cadd extension set had broken off and found separated in bed.There were no adverse events reported.
 
Additional Manufacturer Narrative
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
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11516562
Report Number3012307300-2021-01771
Device Sequence Number14474984
Product Code FPA
UDI-Device Identifier10610586034497
UDI-Public10610586034497
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K974013
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
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 Expiration Date11/24/2025
Device Model Number21-7109-24
Device Lot Number4076788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 02/03/2021
Supplement Date Received by Manufacturer03/31/2021
Initial Report FDA Received Date03/18/2021
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
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