MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. MONOJECT 12ML SYRINGE

Model Number	1181200777T
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a syringe with residuals after infusion of dextrose.No patient harm, medical intervention or hospitalization.Additional devices used: bbraun perfusor space syringe pump.

• Brand Name: MONOJECT 12ML SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• MDR Report Key: 21339853
• Report Number: 1056186-2025-00003
• Device Sequence Number: 19776006
• Product Code: FMF
• UDI-Device Identifier: 10884521179233
• UDI-Public: 10884521179233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/07/2025
• Report Date (Section F): 02/07/2025

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: 1181200777T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/15/2025
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/07/2025