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

Model Number	AH+2732-1M
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During local injection of lidocaine prior to chest tube insertion, by provider, 27g needle broke off luer tip and is currently retained in patient.Provider was at bedside.X-ray ordered.Needle was not removed.Attempted removal during planned surgical procedure needed for other medical condition but unable to safely retrieve, risk of additional harm outweighed benefit of removal.Imaging located retained fragment, no vital organs at risk.Patients' current clinical status: discharged home, stable disclosure to patient with instructions return to hospital if complications arise.No prolonged stay as a result of the unretrievable device fragment.

• 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: 25179452
• Report Number: 8041145-2026-00009
• Device Sequence Number: 10702486
• Product Code: FMI
• UDI-Device Identifier: 00383790002134
• UDI-Public: 00383790002134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: 24K10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2024
• 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; Other
• Patient Sex: Unknown
• Patient Weight: 51 KG