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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL GRIPPER PLUS NEEDLE; FPA - SET, ADMINISTRATION, INTRAVASCULOAR
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SMITHS MEDICAL GRIPPER PLUS NEEDLE; FPA - SET, ADMINISTRATION, INTRAVASCULOAR Back to Search Results
Model Number 21-2767
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
User facility reported device was removed from use with pt and user was unable to lock needle into protection device.No adverse effects to pt or user reported.
 
Manufacturer Narrative
Device evaluation: customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.".
 
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Brand Name
GRIPPER PLUS NEEDLE
Type of Device
FPA - SET, ADMINISTRATION, INTRAVASCULOAR
Manufacturer (Section D)
SMITHS MEDICAL
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4001403
MDR Text Key4690238
Report Number2183502-2014-00449
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-2767
Device Catalogue Number21-2767
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/27/2014
Distributor Facility Aware Date05/08/2014
Event Location Hospital
Date Manufacturer Received06/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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