BoNee® Needle

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.

Brief Statement

Indication
The Bonee needle is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedure.

Contraindications
The Bonee needle is contraindicated for use in patients with the following conditions:

  • Coagulation disorders
  • Any known allergies to the medical device materials
  • Any contraindication related to cystoscopy

Warnings
Ensure that Bonee needle is passed through the cystoscope with the cap fitted, to prevent damage to the working channel and the needle bevel.

Remember to remove the cap before the cystoscope-needle unit is introduced into the patient. If the needle cap is lost in the bladder, it may give rise to infection or stone formation.

Ensure that the working channel of the cystoscope will be compatible with the dimensions of the device (for details, see device label).

Strictly refer to the instructions for use of the injected substance and the clinical injection protocol.

While moving the Bonee needle back and forth, take care to avoid snagging of the needle on the edge of the working channel.

After withdrawal of the device, check for integrity of the needle.

Precautions
The choice of the size of the needle is the responsibility of the physician.

Any use other than stated indications is the responsibility of the physician.

This type of needle must only be used by trained and experienced professionals.

The Bonee needle is provided sterile (ethylene oxide sterilization) and is for single-use only.

Potential Complications
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.

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.

Minneapolis, MN
06/01/2018
PM-04815

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