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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 Device Operational Issue (2914)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
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
It was reported that during use of the listed device with the patient's port, the needle did not separate from the base and could not be removed from the port. This event resulted in an unplanned visit to the emergency room for removal of the port. No permanent adverse health outcome resulted from this event.
 
Manufacturer Narrative
Fifteen unused gripper plus safety needles were returned for investigation, the reported device was not returned. The returned devices were unused and were received in a sealed package. A random sampling of 6 devices were used for investigation. Device examination found that all critical dimensions were within manufacturing specification. During functional testing, the needles were placed in a port and withdrawn; all needles were able to be withdrawn from port with no added effort required. Investigation found all the returned devices to operate as intended and no evidence was found to suggest that the reported event was caused from an intrinsic defect in the product. (b)(4).
 
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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 Key5402298
MDR Text Key37247787
Report Number2183502-2016-00118
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
Type of Report Initial,Followup
Report Date 02/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2020
Device Model Number21-2965
Device Catalogue Number21-2965
Device Lot Number35X1130
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 Received07/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/01/2016 Patient Sequence Number: 1
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