MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. NEEDLE-PRO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4288
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Have been having repeated issues with this specific type needle.This one the safety snapped off (barely touched it) before the needle was used.

• Brand Name: NEEDLE-PRO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8068999
• Report Number: MW5081189
• Device Sequence Number: 13991702
• Product Code: FMI
• UDI-Device Identifier: 20351688046809
• UDI-Public: 20351688046809
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

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 Expiration Date: 07/17/2023
• Device Catalogue Number: 4288
• Device Lot Number: 3664298
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2018
• 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