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

Catalog Number	4428-5
Medical Device Problem Codes	Bent (1059); Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that a jelco® hypodermic needle-pro® needle caused a needlestick injury to a nurse.The nurse had engaged the safety device after subcutaneous administration of lidocaine for intravenous stick and laid the device on the bedside table.It was noted that the nurse felt the safety cap was engaged.During cleanup of the table, the nurse experienced a small prick on the left pinky finger with the needle.It was observed that the needle was sticking out of the safety device and slightly bent.The nurse was put through an exposure protocol and results were negative.No permanent injury was reported.The event was considered resolved.
Additional Manufacturer Narrative
One jelco® hypodermic needle-pro® device was returned for investigation.The device was received without its original packaging.Additionally, photographs of the reported event were provided for review.A review of the device history record, relevant to the reported lot, found no discrepancies or anomalies relevant to the reported event.Visual inspection of the returned device found that the needle was not sticking out of the pro.However, a review of the provided photographs observed that the needle was extending outside of the pro.Investigation determined that there were several possible scenarios which could have resulted in the reported event; however, the root cause of the event could not be established.

• Brand Name: JELCO® HYPODERMIC NEEDLE-PRO® DEVICE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6457415
• Report Number: 3012307300-2017-00797
• Device Sequence Number: 13671624
• Product Code: MEG
• UDI-Device Identifier: 00351688060979
• UDI-Public: 00351688060979
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063755
• 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): 05/31/2017

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: 01/18/2022
• Device Catalogue Number: 4428-5
• Device Lot Number: 3353822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/31/2017
• 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: 22 YR
• Patient Weight: 59