MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ASPIRATION NEEDLE

Model Number	NA-201SX-4022
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that excess force was required to deploy the needle during a lymphadenopathy.The procedure was completed planned.Following the procedure, the user experienced a needle stick as the needle was not retracted into the sheath when it was given to her.It was noted the cause of this is unknown.As a result of the needle puncture, a report was filed in house, the user received a tetanus shot and was tested for (b)(6) along with the patient.They both tested (b)(6).The user is in stable condition.The user's reported weight is (b)(6) pounds.The device was not returned to olympus for evaluation.As reported, the event occurred a result of the needle not being retracted into the sheath.It was noted the cause of this is unknown.
Event or Problem Description
Corrected data: f13- aware date should be 22may2020 as this event became reportable with notification that the user received a tetanus shot.

• Brand Name: SINGLE USE ASPIRATION NEEDLE
• Common Device Name: SINGLE USE ASPIRATION NEEDLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10101603
• Report Number: 2951238-2020-00449
• Device Sequence Number: 17034335
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020
• Report Date (Section F): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NA-201SX-4022
• Device Lot Number: 99V
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 06/10/2020
• 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
• Patient Weight: 70