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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 21-2764-24
Device Problem Fail-Safe Problem (2936)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
Customer contact phone number: (b)(6).
 
Event Description
It was reported that the needle broke apart in the area within the hinge of the deltec gripper plus. More specifically this was observed when pulling and releasing the safety mechanism. The product problem did not cause or contribute to any adverse health effects for the patient.
 
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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 Key11672454
MDR Text Key245754601
Report Number3012307300-2021-03176
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2764-24
Device Catalogue Number21-2764-24
Device Lot Number3998755
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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