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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 Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/02/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical administration set had it's connection part torn off.There was no patient injury.No reported adverse events.
 
Manufacturer Narrative
Other, other text: h3: one cadd extension set from part number 21-7106-24 was received in used condition without its original package.The sample was visually inspected at a distance of 12" under normal conditions of illumination.It was detected that the luer was broken.Current process control were reviewed and no discrepancies were found.The reported issue was unable to be replicated, therefore the issue was not caused by the manufacturing process.
 
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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 Key10546726
MDR Text Key207327304
Report Number3012307300-2020-09426
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 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7106-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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