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

Model Number	JD+03L2219
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Facility reported two needles breaking when giving im(intramuscular) injections.No additional information has been provided, date of event is unknown.

• Brand Name: NIPRO 3CC SYRINGE WITH NEEDLE
• Common Device Name: DISPOSABLE SYRINGE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• MDR Report Key: 13051775
• Report Number: 1056186-2021-00016
• Device Sequence Number: 11139581
• Product Code: FMF
• UDI-Device Identifier: 00383790000758
• UDI-Public: 00383790000758
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021
• Report Date (Section F): 12/21/2021

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 Expiration Date: 08/31/2025
• Device Model Number: JD+03L2219
• Device Lot Number: 20I04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/19/2021
• Device Age: 14 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/21/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2021
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/21/2021