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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; ACCESSORIES FLOW STOP
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ST PAUL CADD; ACCESSORIES FLOW STOP Back to Search Results
Model Number 21-7336-24
Medical Device Problem Codes Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that the cadd administration set - flow stop was broken by the air filter.There were no adverse events reported.
 
Event or Problem Description
Investigation completed on a smiths medical ambulatory infusion pumps|cadd administration sets - flow stop.
 
Additional Manufacturer Narrative
Corrected data: h6 ( patient code).
 
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Brand Name
CADD
Common Device Name
ACCESSORIES FLOW STOP
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10160988
Report Number3012307300-2020-05998
Device Sequence Number2680630
Product Code FPA
UDI-Device Identifier10610586027291
UDI-Public10610586027291
Combination Product (Y/N)N
Initial Reporter CountryDA
PMA/510(K) Number
K040636
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,Followup
Report Date (Section B) 08/11/2020
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 Expiration Date01/28/2025
Device Model Number21-7336-24
Device Catalogue Number21-7336-24
Device Lot Number3931548
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/18/2020
Supplement Date Received by Manufacturer05/18/2020
05/18/2020
Initial Report FDA Received Date06/17/2020
Supplement Report FDA Received Date06/17/2020
08/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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