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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO NEEDLE, HYPODERMIC, SINGLE LUMEN

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SMITHS MEDICAL ASD, INC JELCO NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 4291
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 05/24/2018
Event Type  malfunction  
Event Description
The needle comes off from the threaded hub when aspirating sterile diluent.
 
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Brand NameJELCO
Type of DeviceNEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7560367
MDR Text Key109785375
Report Number7560367
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4291
Device Lot Number3520819
Other Device ID NumberHYPODERMIC NEEDLE-PRO 25G 5/8
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/29/2018
Event Location No Information
Date Report to Manufacturer05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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