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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW; SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7322-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  malfunction  
Manufacturer Narrative
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 reportable information becomes available.Lot/serial number not provided.
 
Event Description
It was reported that the patient was receiving epoch.It was reported that the drug didn't infuse from 3/2/22 to 3/3/22.No patient injury was reported.
 
Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be completed.Device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.No lot number was provided; therefore, dhr (device history review) could not be performed.
 
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Brand Name
CADD ADMINISTRATION SETS WITH FLOW STOP FREE-FLOW
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
suite 10
minneapolis, MN 55442
MDR Report Key15236960
MDR Text Key304688694
Report Number3012307300-2022-15469
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/10/2022
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
Device Operator Lay User/Patient
Device Catalogue Number21-7322-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/13/2022
Initial Date FDA Received08/16/2022
Supplement Dates Manufacturer Received09/13/2022
Supplement Dates FDA Received10/10/2022
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
Patient Sequence Number1
Patient Age30 YR
Patient SexFemale
Patient Weight65 KG
Patient EthnicityNon Hispanic
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