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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., DELTEC® GRIPPER® SAFETY NEEDLES INTRAVASCULAR ADMINISTRATION SET.

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SMITHS MEDICAL ASD INC., DELTEC® GRIPPER® SAFETY NEEDLES INTRAVASCULAR ADMINISTRATION SET. Back to Search Results
Device Problems Activation, Positioning or SeparationProblem (2906); 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
The user facility reported that during the removal of the listed device from the patient, the safety mechanism could not be engaged over the needle. No needle-stick took place. No adverse health effects to the patient or nurse were reported.
 
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Brand NameDELTEC® GRIPPER® SAFETY NEEDLES
Type of DeviceINTRAVASCULAR ADMINISTRATION SET.
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 rd.
st. paul, MN 55112
7633833052
MDR Report Key5684878
MDR Text Key46081517
Report Number2183502-2016-01097
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 05/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2016
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 Initial

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