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	Malfunction
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.
Event or Problem Description
Facility reported two needles breaking when giving im(intramuscular) injections.No additinoal information has been provided, date of event is unknown.
Additional Manufacturer Narrative
01/26/2022: investigation report attached is on retained samples only.

• 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,
• 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: 13051729
• Report Number: 8041145-2021-00017
• Device Sequence Number: 14637131
• Product Code: FMF
• UDI-Device Identifier: 00383790000758
• UDI-Public: 00383790000758
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/26/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• 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: Required Intervention
• Patient Sex: Unknown