MAUDE Adverse Event Report: PROMISEMED HANGZHOU MEDITECH CO., LTD. ASSURE ID SAFETY PEN NEEDLES; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	275130
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The incident with the needlestick did not happen with the reporter, it happened with another nurse in the facility.As far as the reporter is aware, the device appeared to be in good condition prior to use.When removing the needle from the insulin pen, the device fell apart and the needle was exposed, and the spring was still around the needle and the nurse who was administering the insulin was stuck twice in the finger with the exposed needle.The reporter said the pt who was administered the insulin did not have any known infectious diseases.The nurse who was stuck with the needle cleaned the area thoroughly with soap and water and alcohol.The nurse was sent to another location within the parent company to have bloodwork done to test for any infectious diseases.Her bloodwork report came back as being negative for any infectious disease.Fda safety report id# (b)(4).

• Brand Name: ASSURE ID SAFETY PEN NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): PROMISEMED HANGZHOU MEDITECH CO., LTD.
• MDR Report Key: 9124394
• Report Number: MW5090056
• Device Sequence Number: 11357120
• Product Code: FMI
• UDI-Device Identifier: 50015482275315
• UDI-Public: (01)50015482275315
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 06/30/2023
• Device Model Number: 275130
• Device Catalogue Number: 275130
• Device Lot Number: 607081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1