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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL GRIPPER PLUS NEEDLE
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SMITHS MEDICAL GRIPPER PLUS NEEDLE Back to Search Results
Model Number 21-3466
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/02/2014
Event Type  malfunction  
Event Description
User facility reported that the device was removed from use with patient and user was unable to lock needle into protection device.No adverse effects to patient or user reported.
 
Manufacturer Narrative
The device is currently being evaluated; the mfr will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).
 
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Brand Name
GRIPPER PLUS NEEDLE
Manufacturer (Section D)
SMITHS MEDICAL
st. paul MN
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key3967099
MDR Text Key20654943
Report Number2183502-2014-00388
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/28/2019
Device Model Number21-3466
Device Catalogue Number21-3466-24
Device Lot Number34X223
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/14/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2014
Distributor Facility Aware Date05/02/2014
Device Age2 MO
Event Location Hospital
Date Manufacturer Received05/08/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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