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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN
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SMITHS MEDICAL ASD, INC. JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Catalog Number 401815
Medical Device Problem Code Protective Measures Problem (3015)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/10/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.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 or Problem Description
It was reported that immediately upon use, the safety device of a new jelco® hypodermic needle-pro® edge¿ "got in the way" while injecting.No injury to patient or clinician was reported.
 
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Brand Name
JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE
Common Device Name
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key6541819
Report Number3012307300-2017-01005
Device Sequence Number10961808
Product Code FMI
UDI-Device Identifier00351688070831
UDI-Public00351688070831
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K071785
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number401815
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2017
Initial Report FDA Received Date05/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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