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

Model Number NA-201SX-4022

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 03/19/2020

Event Type  Injury  

Event 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 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
• Type of Device: 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
• MDR Text Key: 195125512
• Report Number: 2951238-2020-00449
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 04953170180972
• UDI-Public: 04953170180972
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/22/2020,06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 70