MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® HYPODERMIC NEEDLE-PRO® FIXED NEEDLE INSULIN SYRINGE; SYRINGE, ANTISTICK

Catalog Number	ED12905-IN
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/25/2017
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 when picking up a used jelco® hypodermic needle-pro® fixed needle insulin syringe, the nurse experienced a needle stick.The nurse had used the desk top to engage the safety device after completing the injection.The nurse went on to complete the "med pass", including a second injection.After completion, the nurse picked up both syringes at the same time to discard, which is when the needle stick occurred.No permanent injury was reported.
Additional Manufacturer Narrative
Two photos were provided for evaluation.No product was returned for evaluation.Photographic inspection of the photos showed the needle cannula was slightly bent to the left side and upwards.Without the actual sample for testing, the root cause of the issue was unable to be determined and the complaint was unable to be confirmed.

• Brand Name: JELCO® HYPODERMIC NEEDLE-PRO® FIXED NEEDLE INSULIN SYRINGE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6609322
• Report Number: 3012307300-2017-01165
• Device Sequence Number: 19104868
• Product Code: MEG
• UDI-Device Identifier: 15019517065596
• UDI-Public: 15019517065596
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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: 12/31/2021
• Device Catalogue Number: ED12905-IN
• Device Lot Number: 3346309
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 06/02/2017
• Supplement Report FDA Received Date: 07/12/2017
• 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