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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 21-7106-24
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical tubing was unable to be connected to a mating component.The male luer connection was the defective component on the tubing.The customer suspects that the diameter of the connector was larger than that of a normal one.There were no adverse events reported.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Results: the result for diameter of the end of the male conical fitting did not meet without specification.Problem source was traced to the supplier.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
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11115097
MDR Text Key225039832
Report Number3012307300-2021-00051
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586023279
UDI-Public10610586023279
Combination Product (y/n)N
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7106-24
Device Lot Number3955140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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