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

Model Number	AH+2538-1M
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reports while the doctor was taking a urine sample through cystotomy, the needle disconnected from its hub and was left in the abdominal cavity of a canine.The needle separated after aspiration and removal from the abdominal cavity.They had to sedate, take x-rays, and perform surgery on the canine.The needle was retrieved intact.No complications after surgery.

• 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: 25183491
• Report Number: 1056186-2026-00021
• Device Sequence Number: 10653181
• Product Code: FMI
• UDI-Device Identifier: 00383790002080
• UDI-Public: 00383790002080
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/15/2026
• Report Date (Section F): 05/15/2026

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+2538-1M
• Device Lot Number: 25K19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2026
• Device Age: 3 MO
• Event Location: Other
• Date Report to Manufacturer: 05/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/15/2026