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.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Pending return of samples from customer for further investigation.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Pending return of samples from customer for further investigation.03/21/25: customer never returned samples.Final investigation attached is on retained representative lot since the lot number for the reported product was unknown.
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,
• 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: 21339917
• Report Number: 8041145-2025-00003
• Device Sequence Number: 8623862
• Product Code: FMF
• UDI-Device Identifier: 10884521179233
• UDI-Public: 10884521179233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown