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U.S. Department of Health and Human Services

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

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ST PAUL DELTEC GRIPPER PLUS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-2768-24
Device Problem Fail-Safe Problem (2936)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2021
Event Type  malfunction  
Manufacturer Narrative
Customer contact phone number: (b)(6).
 
Event Description
It was reported that the deltec gripper plus was removed from use with patient and the user attempted to withdraw the metal needle into the safety mechanism. The reporter stated that the device broke apart and the safety arm was detached from the rest of the device. No adverse effects to patient or user were reported.
 
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Brand NameDELTEC GRIPPER PLUS
Type of DeviceSET, 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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11675359
MDR Text Key245752462
Report Number3012307300-2021-03185
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
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 Catalogue Number21-2768-24
Device Lot Number4046719
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 Manufactured09/25/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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