The BoNee Bladder Injection needle is a single-use device used to deliver low viscosity injectable medications to the urinary bladder wall during transurethral endoscopic procedures. The BoNee needle is available in two sizes, 35 cm and 70 cm, for use with either a rigid or flexible cystoscope.
For ordering information, please call 800-258-3476.
Bonee® Brief Statement
The Bonee needle is used to deliver injectable materials, amongst other Botulinum toxin, into the urinary bladder wall during the transurethral endoscopic procedure.
The Bonee needle is contraindicated for use in patients with the following conditions:
- coagulation disorders
- any know allergies to the medical device materials
- any contraindication related to cystoscopy or to the injected substance
Refer to the instructions for use of the injected substance and the clinical injection protocol.
The choice of the size of the needle is the responsibility of the physician.
This type of needle must only be used by trained and experienced professionals.
Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient.
Potential complications related to injection into the bladder wall include: bleeding, bladder wall perforation. Potential complications related to the passage of the cystoscope-needle unit into the bladder include: tears or perforation of the meatus and/or the urethra if the device is advanced with the needle protruding, pain, urinary tract infection. For injected substance related adverse effects, please refer to its instructions for use.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.