MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO HYPODERMIC NEEDLES

Model Number	AH+3013-1M
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was injecting the left side of the neck, during the epidermal inclusion cyst excision, using needle.When retracting, the syringe, the needle became detached from the needle hub and was no longer attached to cap.Instead it remained in injection site with no way of retrieving.Patient saw a plastic surgeon, who was unable to remove the needle.Patient is scheduled for a second visit with a plastic surgeon.No further information has been provided.

• Brand Name: NIPRO HYPODERMIC NEEDLES
• Common Device Name: HYPODERMIC NEEDLES
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 9832498
• Report Number: 1056186-2020-00002
• Device Sequence Number: 3068482
• Product Code: FMI
• UDI-Device Identifier: 00383790002141
• UDI-Public: 00383790002141
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020
• Report Date (Section F): 03/13/2020

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: 10/31/2023
• Device Model Number: AH+3013-1M
• Device Catalogue Number: AH+3013-1M
• Device Lot Number: 18K08
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2020
• Device Age: 13 MO
• Event Location: Other
• Date Report to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2020
• 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; Required Intervention
• Date Report Sent to FDA: 03/13/2020