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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.
 
Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
DELTEC
Type of Device
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11287879
MDR Text Key230672085
Report Number3012307300-2021-00926
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586029745
UDI-Public10610586029745
Combination Product (y/n)N
PMA/PMN Number
K072059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/28/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model Number21-3251-24
Device Catalogue Number21-3251-24
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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