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

Catalog Number	402515
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/04/2017
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 the safety of a jelco® hypodermic needle-pro® edge¿ safety device didn't work, causing the nurse to be stuck by the needle.No permanent injury was reported.
Event or Problem Description
The nurse was seen and evaluated in the emergency room.No medical treatment was required.The nurse required additional testing after initial exposure to confirm no conversion of (b)(6).

• 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: 6732438
• Report Number: 3012307300-2017-01597
• Device Sequence Number: 817016
• Product Code: FMI
• UDI-Device Identifier: 20351688075502
• UDI-Public: 20351688075502
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: Nurse
• Device Expiration Date: 02/16/2022
• Device Catalogue Number: 402515
• Device Lot Number: 3378153
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/18/2017
• 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