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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 21-2770
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
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
Customer has not yet returned the device to the mfr for device eval.When and if the device becomes available and is returned and evaluated, the mfr will file a follow-up report detailing the results.
 
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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 Key4593628
MDR Text Key5483560
Report Number2183502-2015-00112
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 Pharmacist
Type of Report Initial
Report Date 03/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/01/2016
Device Model Number21-2770
Device Catalogue Number21-2770
Device Lot Number31X1032
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2015
Device Age3 YR
Event Location Hospital
Date Manufacturer Received02/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
PORT-A-CATH
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