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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. GRIPPER PLUS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD INC. GRIPPER PLUS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2965
Device Problem Fail-Safe Problem (2936)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
User facility reported 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.
 
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Brand NameGRIPPER PLUS NEEDLE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.
1265 grey fox road
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox road
st. paul, MN 55112
7633833052
MDR Report Key5380977
MDR Text Key36448064
Report Number2183502-2016-00082
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
Type of Report Initial
Report Date 01/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2020
Device Model Number21-2965
Device Catalogue Number21-2965
Device Lot Number35X987
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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