Bard PureWick - Product Overview and Safety; Indications for Use; Intended Users and Contraindications; General Safety Warnings

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Indication for use:
The PureWick
TM
Female External Catheter is intended for non-invasive urine output
management in adult female patients.
Intended Users:
• User/Patient
• Caregiver/Healthcare Professional
Contraindications:
• Patients with urinary retention
Warnings:
• Never insert the P
ureWick
TM
Female External Catheter into vagina, anal canal,
or other body cavities. FOR EXTERNAL USE ONLY.
• Do not use the PureWick
TM
Female External Catheter with bedpan or any material
that does not allow for sufficient airflow.
• To avoid potential skin injury, never push or pull the PureWick
TM
Female External
Catheter against the skin during placement or removal.
• Discontinue use if an allergic reaction occurs.
• Reuse and/or repackaging may create a risk of patient or user infection, compromise
the structural integrity and/or essential material and design characteristics of the
device which may lead to device failure, and/or lead to injury or illness of the patient.
• After use, this product may be a potential biohazard. Dispose of in accordance
with applicable local, state and federal laws and regulations.
Precautions:
• Not recommended for patients who are:
▫
Agitated, combative, or uncooperative and might remove the P
ureWick
TM
Female
External Catheter
▫
Having frequent episodes of bowel incontinence without a fecal management
system in place
▫
Experiencing skin irritation or compromise at the site
▫
Experiencing moderate/heavy menstruation and cannot use a tampon
• When using the PureWick
TM
Female External Catheter, do not use barrier cream on the
perineum, as this may impede suction.
• Proceed with caution in patients who have undergone recent surgery of the external
urogenital tract.
• Always assess skin for compromise and perform perineal care prior to placement of
a new PureWick
TM
Female External Catheter.
• Maintain suction until the PureWick
TM
Female External Catheter is fully removed from
the patient to avoid urine backflow.
Recommendations:
• Perform each step with clean technique. In the home setting, wash hands thoroughly
before device placement.
• Prior to connecting the P
ureWick
TM
Female External Catheter to hospital wall suction
tubing, verify suction function by covering the open end of the suction tubing with
one hand and observing the pressure dial. If the pressure does not increase when
the line is covered, verify that the tubing is secured, connected, and not kinked.
• Ensure the PureWick
TM
Female External Catheter remains in the correct position
after turning the patient. Remove the PureWick
TM
Female External Catheter prior
to ambulation.
• Properly placing the PureWick
TM
Female External Catheter snugly between the labia
and gluteus holds the PureWick
TM
Female External Catheter in place for most patients.
Mesh underwear may be useful for securing the PureWick
TM
Female External Catheter
for some patients.
• Assess device placement and patient’s skin at least every 2 hours.
• Replace the PureWick
TM
Female External Catheter every 8-12 hours or if soiled
with feces or blood.
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