BD Nexiva, BD Q-Syte recallZ-0306-2022 · Becton Dickinson Infusion Therapy Systems Inc. · initiated Sep 8, 2021

Why it was recalled

There is a breach in the product packaging that renders the product non-sterile.

FDA root cause category: Packaging process control

What the company is doing

On September 30, 2021, the firm sent out a customer notification letter "Urgent Medical Device Recall" to their customers via Fed-Ex with the instruction due to the packaging breach, identified during the in house internal leak testing. This breach in the product packaging rendered the enclosed IV catheters non-sterile. Holes have been detected on the bottom tray of device unit packages. The notification stated to destroy the devices which are present in customers/distributors inventory. The recalling firm notified in a customer notification letter to fill and send the customer response form with customer's details and acknowledgement of destruction of the device list , lot number and quantities for the replacement. The contact information will be provided for the customers to call : 1-844-8BD-LIFE (1-844-823-5433)Say Recall when prompted, Mon Fri 8:00am and 5:00pm CT or Email: [email protected] The customer response form to be returned via: E-Mail [email protected], Fax No. is 312-949-0375.

Recall details

Recall number

Z-0306-2022

Status

Open, Classified

Initiated by the company

Sep 8, 2021

Recalling firm

Becton Dickinson Infusion Therapy Systems Inc.

Quantity

155,840 devices, 80 units in each box

Product code

FOZ

FDA submissions

K183399

Distribution

U.S. Nationwide Distribution: AR, AZ, MA, GA, NC, OH, WA, NY, NJ, HI, CA, MD, RI, MT, IN, PA, IL OK, OR, AK, CT, TX, ME, MO, FL, VA, LA, CO, UT O.U.S.: None

Product description

BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV catheter systems are over-the-needle, intravascular catheters. These devices have a radiopaque BD Vialon" catheter, needle, needle shield, septum, stabilization platform, integrated extension tubing, clamp, dual port adapter, vent plug and pre-attached BD Q-Syte Luer Access Split Septum. The needle and catheter are protected by a needle cover. A BD Q-Syte device or an end cap with protective cover is provided in the unit package. The closed system is designed to keep blood contained within the device throughout the insertion process. The septum is designed to wipe visible blood from the needle surface as the needle is withdrawn from the catheter, further reducing the risk of blood exposure. The needle tip is passively protected when the needle is removed, reducing the risk of accidental needlestick injury. These devices have BD Instaflash" Needle Technology, allowing for immediate visualization of blood along the catheter. Continuous blood return is seen in the extension tubing. The vent plug prevents blood leakage from the extension tubing during insertion. Both the stabilization platform and dual port adapter are color coded to indicate catheter gauge size (24GA (0.7 mm)=Yellow, 22GA (0.9 mm)=Blue, 20GA (1.1 mm)=Pink, 18GA (1.3 mm)=Green). BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kPa) when access ports not suitable for use with power injectors are removed.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BD Nexiva, BD Q-Syte 383536

  Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days
  2 recalls374 reports

Product lines

• BD Nexiva, BD Q-SyteBecton, Dickinson And Company · 8 models · 1,154 reports · 4 recalls