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

Model Number	AH+2732-1M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During preparation for a pacemaker insertion, the needle broke at the hub inside the subcutaneous tissue on the left upper chest area.Fluoroscopy had to be used to locate the needle, surgeon was able to incorporate an incision into the pacemaker pocket incision, and removed the broken piece with forceps.The procedure was then completed without any other impact to the patient or complications.

• Brand Name: NIPRO HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• MDR Report Key: 21339178
• Report Number: 1056186-2025-00001
• Device Sequence Number: 8624344
• Product Code: FMI
• UDI-Device Identifier: 00383790002134
• UDI-Public: 00383790002134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2025
• Report Date (Section F): 02/07/2025

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 Model Number: AH+2732-1M
• Device Lot Number: 23J02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/13/2025
• Device Age: 13 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 02/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/07/2025