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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC NEEDLE, HYPODERMIC, SINGLE LUMEN

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ST PAUL DELTEC NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 21-3251-24
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/24/2020
Event Type  malfunction  
Event Description
It was reported the device had been in use with patient and user had captured the needle in the safety mechanism. Reporter stated the needle came out of the safety mechanism and user sustained needle stick. User was given user facility's needle stick protocol. Further information has been requested and not received at this time.
 
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Brand NameDELTEC
Type of DeviceNEEDLE, HYPODERMIC, SINGLE LUMEN
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 Key11287959
MDR Text Key230664403
Report Number3012307300-2021-00927
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-3251-24
Device Catalogue Number21-3251-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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