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

Model Number	AH+2516-1M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unused samples from the same lot have been shipped to the factory for investigation.Pending investigation findings.
Event or Problem Description
During im injection in the right thigh for pre-op medications during a neuter procedure, needle appeared to slip out of the hub.Needle is visible upon x-ray.The canine appears to be recovering normally with no problems.Hub was discarded.The facility contacted a surgical specialist when the incident occurred and they were advised to leave the needle in place.It was explained that attempting to find the small needle, it could cause more damage to the muscle group, rather than allowing it to remain as it might eventually work its way out on its own.Facility was instructed to have an x-ray of the site at least one or twice a year, to monitor the position of the needle.No additional information has been provided.
Additional Manufacturer Narrative
Unused samples from the same lot have been shipped to the factory for investigation.Pending investigation findings.
Event or Problem Description
During im injection in the right thigh for pre-op medications during a neuter procedure, needle appeared to slip out of the hub.Needle is visible upon x-ray.The canine appears to be recovering normally with no problems.Hub was discarded.The facility contacted a surgical specialist when the incident occurred and they were advised to leave the needle in place.It was explained that attempting to find the small needle, it could cause more damage to the muscle group, rather than allowing it to remain as it might eventually work its way out on its own.Facility was instructed to have an x-ray of the site at least one or twice a year, to monitor the position of the needle.No additional information has been provided.

• 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: 22378378
• Report Number: 8041145-2025-00007
• Device Sequence Number: 8429983
• Product Code: FMI
• UDI-Device Identifier: 00383790002066
• UDI-Public: 00383790002066
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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+2516-1M
• Device Lot Number: 24I22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2024
• 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; Required Intervention; Other
• Patient Sex: Unknown