MAUDE Adverse Event Report: NIPRO MEDICAL CORPORATION NIPRO HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	AH+2732
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During local injection of lidocaine by provider, 27g needle broke off luer tip and is currently retained in pt.Provider is at bedside.Xr [xray] called.

• Brand Name: NIPRO HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): NIPRO MEDICAL CORPORATION; 3150 nw 107th ave; doral FL 33172
• MDR Report Key: 24290533
• Report Number: 24290533
• Device Sequence Number: 10247637
• Product Code: FMI
• UDI-Device Identifier: 00383790002134
• UDI-Public: (01)00383790002134(17)291031(10)24K10
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026
• Report Date (Section F): 01/28/2026

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
• Device Catalogue Number: AH+2732-1M
• Device Lot Number: 24K10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 52 KG
• Date Report Sent to FDA: 01/28/2026