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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem Pulmonary Hypertension (4460)
Event Date 01/01/2023
Event Type  malfunction  
Event Description
It was reported that there was an increase in the number of complaints related to leaking of the extension set.Per reporter sixty-seven (67) patients were affected between january to june, 2023.No major patient injury issues were reported but some patients mentioned exhibiting pulmonary arterial hypertension symptoms.
 
Manufacturer Narrative
Other, other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.D4, g5, h4: lot and item number unavailable at time of reporting.
 
Manufacturer Narrative
No lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.
 
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Brand Name
CADD EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17350912
MDR Text Key319317294
Report Number3012307300-2023-07247
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/02/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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