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

Model Number	JD+03L2238
Medical Device Problem Codes	Material Disintegration (1177); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has been using the 3ml 22g x 1.5'' syringe to draw and inject progesterone in ethyl oleate 50 mg/ml.She claimed the product was never in direct sunlight and was outside of her house for about 5 minutes before bringing in the package.She is reporting long term side effects from using the syringe, including injection site pain whole body chills, aches and fever.According to additional information received from the end-user, the patient's husband was trained on how to administer injections.Patient began using progesterone in ethyl oleate on (b)(6) 2024.Patient had an unopened bottle when the second cycle began on (b)(6) 2024.Patient was advised by her fertility team that the unused product could be used during the second cycle.Used the medication for the 4 days that the "faulty" syringes were used, then discarded the remaining medication fearing it was contaminated.Medication is administered im(intramuscular) in the gluteal muscle.Patient began experiencing symptoms of soreness at the injection site, along with muscle knot, around 8 hours after the injection was given.By the evening of (b)(6) 2024 patient started to feel an increase in soreness and developed low grade fever of 99.5 degrees f.Patient continued to administer the injections despite the symptoms, on (b)(6) 2024.Each day following the injection, noting that it was extremely difficult to inject the medication.After administering the medication on (b)(6) 2024, the patient's husband inspected the syringe and tested the plunger to make sure it moved freely but noticed that there was black debris inside the syringe barrel that appeared to be coming off the plunger.Patient stated that they began using another brand of syringes stating their symptoms subsided within 24hours of changing the syringe.

• Brand Name: NIPRO 3ML SYRINGE WITH NEEDLE
• 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: 19660221
• Report Number: 8041145-2024-00009
• Device Sequence Number: 12397159
• Product Code: FMF
• UDI-Device Identifier: 00383790000789
• UDI-Public: 00383790000789
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2024

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: 23H13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2023
• 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: Female