MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO DISPOSABLE SYRINGE W/ NEEDLE; SYRINGE - 3CC- WITH NEEDLE

Model Number	JD+03L2525
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
We received several emails from the customer reporting inflammation and pain in the leg.Customer explained in the emails that during medicine administration the plunger falls apart, his leg became severely inflammed and the patient had to take anti-inflammatory ordered by his doctor.He is waiting for the doctor to confirm whether or not he has pieces of the plunger in his leg.Note: customer did not provide date of occurrence, did not provide the name of the medication used during the administration, did not advise type of testing performed to confirm whether or not pieces of the plunger were in his leg.Customer purchased our syringes from an unauthorized distributor online.No further information has been provided.

• Brand Name: NIPRO DISPOSABLE SYRINGE W/ NEEDLE
• Common Device Name: SYRINGE - 3CC- WITH NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,?, 13110 ; TH 13110
• MDR Report Key: 8269127
• Report Number: 8041145-2019-00001
• Device Sequence Number: 2056449
• Product Code: FMF
• UDI-Device Identifier: 00383790000833
• UDI-Public: 00383790000833
• Combination Product (Y/N): N
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: JD+03L2525
• Device Lot Number: 18H08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/22/2019
• 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: Required Intervention