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

Model Number JD+03L2525

Device Problem Material Disintegration (1177)

Patient Problems Inflammation (1932); Pain (1994)

Event Type  Injury  

Event 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 on-line.No further information has been provided.

• Brand Name: NIPRO DISPOSABLE SYRINGE W/ NEEDLE
• Type of Device: SYRINGE - 3CC- WITH NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,?, 13110 ; TH 13110
• MDR Report Key: 8269136
• MDR Text Key: 133829629
• Report Number: 1056186-2019-00001
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00383790000833
• UDI-Public: 00383790000833
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: JD+03L2525
• Device Lot Number: 18H08
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2019
• Distributor Facility Aware Date: 12/29/2018
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention