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

Model Number	AH+2219-1M
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The hypodermic needle broke off at the hub during use, when attempting to sedate the animal.The broken needle had to be removed from the animal.No further information was provided.
Additional Manufacturer Narrative
Investigation report attached is on retained samples only, actual sample was not available for investigation.- (b)(4).
Event or Problem Description
The hypodermic needle broke off at the hub during use, when attempting to sedate the animal.The broken needle had to be removed from the animal.No further information was provided.

• 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: 9235673
• Report Number: 8041145-2019-00010
• Device Sequence Number: 11414577
• Product Code: FMI
• UDI-Device Identifier: 00383790001977
• UDI-Public: 00383790001977
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: AH+2219-1M
• Device Lot Number: 18D20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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