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	Malfunction
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Investigation is ongoing on returned samples.
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.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Investigation is ongoing on returned samples.
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,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 21339541
• Report Number: 8041145-2025-00001
• Device Sequence Number: 3849579
• Product Code: FMI
• UDI-Device Identifier: 00383790002134
• UDI-Public: 00383790002134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown