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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC GRIPPER MICRO HUBER NEEDLE

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SMITHS MEDICAL ASD, INC. DELTEC GRIPPER MICRO HUBER NEEDLE Back to Search Results
Catalog Number 21-3277-24
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/1959
Event Type  malfunction  
Event Description
The patient's port was accessed using a gripper micro/huber needle without difficulty. When the rn attempted to retract the inner needle so only the blunt tip needle would be in place, the inner needle was unable to be retracted. The clinician attempted to retract the needle and was also unable to retract it. The port was deaccessed and was reaccessed using a new needle, which functioned properly.
 
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Brand NameDELTEC GRIPPER MICRO
Type of DeviceHUBER NEEDLE
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
st. paul MN 55112
MDR Report Key6618420
MDR Text Key77002422
Report NumberMW5070203
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-3277-24
Device Lot Number35X991
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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