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

Model Number	UNKNOWN
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation report attached is on representative retained samples from the manufacturer.Customer did not record product information, and discarded used samples.
Event or Problem Description
The hypodermic needle the hypodermic needle broke off at the junction with the hub during use, part of the needle was still visible and staff was to extract the needle with forceps.Exact date of event is unknown (between (b)(6) and (b)(6) 2019).Actual product code is unknown.Facility distributor does not record product shipped to their customer.Product code and lot is obtain only if the customer reports a complaint.Customer did not report this incident to their distributor, and they did not retain product information either.Since this is the same customer from the previous complaint, and they reported product code ah+2219-1m for the previous incident, we ran a report to pull lots for this code (ah+2219-1m), shipped to their distributor.Possible lots are: 17l06, 18a10, 18b08, 18b08, 18d20.

• 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: 9241890
• Report Number: 8041145-2019-00014
• Device Sequence Number: 19305856
• 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
• 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 Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial 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