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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL GRIPPER PLUS NEEDLE; FPA - SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL GRIPPER PLUS NEEDLE; FPA - SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A report was rec'd that, following an infusion, a clinician was removing the device from use with a patient.During removal of the device, the clinician attempted to activate the safety mechanism by pulling back on the arm; the arm and needle were over extended past the safety position and then broke away from the device base.As a result the needle remained exposed.No needlestick took place.There was no patient or clinician injury.
 
Manufacturer Narrative
Manufacturer completed the entire form.Additional manufacturer narrative: the device is currently being evaluated; the manufacturer will file a f/u report detailing the results of the evaluation once it is completed.
 
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Brand Name
GRIPPER PLUS NEEDLE
Type of Device
FPA - SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3695458
MDR Text Key16593485
Report Number2183502-2014-00009
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 02/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/30/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2014
Event Location Hospital
Initial Date Manufacturer Received 01/06/2014
Initial Date FDA Received02/04/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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