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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL DELTEC SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2766-24
Device Problems Fail-Safe Problem (2936); Fail-Safe Did Not Operate (4046)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
After removing the product from the patient, the customer pulled up the arm, but the safety lock mechanism did not work. No patient injury.
 
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Brand NameDELTEC
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key11391034
MDR Text Key233947524
Report Number3012307300-2021-01635
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2766-24
Device Catalogue Number21-2766-24
Device Lot Number3971831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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