MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO 3ML SYRINGE WITH NEEDLE

Model Number	JD+03L2238
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We received unused samples from the customer and shipped to factory for investigation.
Event or Problem Description
(11/25/24): issue reported as "syringe is leaking," but no lot number provided.The medication being used is "progesterone in oil." (12/18/24): 2 total events.Issues reported as "hard to push the plunger" and "hard to draw and inject medication," with lot number 24g22 provided for one event.The medication being used is "progesterone in oil." (12/18/24): issue reported as "particles/rubber stopper pieces sticking to the walls of the syringe," with no lot number provided.The medication being used is "progesterone in oil.".

• Brand Name: NIPRO 3ML SYRINGE WITH NEEDLE
• Common Device Name: SYRINGE WITH 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: 21340003
• Report Number: 8041145-2025-00004
• Device Sequence Number: 8432018
• Product Code: FMF
• UDI-Device Identifier: 00383790000789
• UDI-Public: 00383790000789
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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: JD+03L2238
• Device Lot Number: 24G22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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: Other
• Patient Sex: Unknown