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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 21-3257-24
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that while a nurse tried to remove gripper micro to remove needle after port access but was unable to do so. A second nurse attempted without success so the line was removed and a new needle used to access without issues. Tried to pull back to release gripper after it was removed from patient but still was unsuccessful. No adverse patient effects were reported.
 
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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
minneapolis, MN 55442
MDR Report Key11781488
MDR Text Key249205741
Report Number3012307300-2021-03891
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number21-3257-24
Device Catalogue Number21-3257-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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