MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	401810
Medical Device Problem Codes	Bent (1059); Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/12/2017
Type of Reportable Event	Serious Injury
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 a jelco® hypodermic needle-pro® edge¿ safety device was in use with a patient when the user attempted to activate the safety lock on the needle, which caused the needle to pop off and caused a needlestick to the user.It was noted that as the device was pressed against a hard surface, the needle bent.Due to the needlestick, the user followed a bloodborne pathogen protocol.No patient injury was reported.No medical treatment was conducted.
Event or Problem Description
It was further reported that the user continued with post exposure testing.

• 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 Key: 6312306
• Report Number: 3012307300-2017-00324
• Device Sequence Number: 16329727
• Product Code: FMI
• UDI-Device Identifier: 30351688069782
• UDI-Public: 30351688069782
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K071785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 401810
• Device Lot Number: 3193287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 03/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 31 YR