MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. NIPRO HYPODERMIC NEEDLE

Model Number	AH+2516-1M
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Needle broke off in patient during use.Needle also broke again when being surgically removed.No additional information was provided.((b)(6) female spayed, aussie shepherd mix, (b)(6)).

• Brand Name: NIPRO HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,, 13110 ; TH 13110
• MDR Report Key: 9782207
• Report Number: 1056186-2020-00001
• Device Sequence Number: 19004730
• Product Code: FMI
• UDI-Device Identifier: 00383790002066
• UDI-Public: 00383790002066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2020
• Report Date (Section F): 03/03/2020

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: 04/30/2023
• Device Model Number: AH+2516-1M
• Device Catalogue Number: AH+2516-1M
• Device Lot Number: 18E07
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/03/2020
• Device Age: 20 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2020
• 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: Other; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 28
• Date Report Sent to FDA: 03/03/2020