Device Description - Bard 000257 Manual Del Usuario

NON-STERILE
NON
STERILE

Device Description

The Bard* Button Device Bolus Feeding Tube with Straight Adaptor is a 10" (24.5
cm) bolus feeding tube including a clamp, straight adaptor and 60 cc (ml) syringe,
designed specifically for use with the Bard* Button replacement gastrostomy
device.
The following chart indicates the appropriate bolus feeding tube to be used with
the various sized Bard* Button replacement gastrostomy devices:
Bolus Feeding Tube and Size
REF 000257 18F (6.0 mm)
REF 000259 24F (8.0 mm)
REF 000269 28F (9.3 mm)
Indications for Use
To deliver enteral feeding and/or medication into the Bard* Button replacement
gastrostomy device in patients requiring long-term nutritional support.
Contraindications
Include use of this device with any product other than the Bard* Button replace-
ment gastrostomy device; or for indications other than delivering feeding nutri-
ents and/or medication.
Warning
Rx Only : Federal (U.S.A.) law restricts this device to sale by or on the order of a physi-
cian.
Intended for Single Patient Use. Use of this device in more than a single patient in-
creases the risk of cross-contamination of infectious diseases between patients.
After use, this product may be a potential biohazard. Handle and dispose of
in accordance with accepted medical practice and applicable local, state and
federal laws and regulations.
Precaution
Too much pressure may cause the Button device to be pushed into the stomach or to
be prematurely pulled out of the stomach.
Adverse Reactions
May include: minor wound infection or pressure necrosis at stoma site; leakage of
gastric contents; gastrocolic fistula; and gastric separation leading to peritonitis,
sepsis and death. All of these potential complications increase in likelihood with
improper placement. If the stoma measuring device is pulled too tightly against
the stomach wall an improperly sized, i.e., too short, replacement device may be
selected.
Attention, see instructions for use
Bard* Button Device and Size
REF 000292
REF 000282
REF 000283
REF 000284
REF 000293
REF 000285
REF 000286
REF 000287
REF 000296
REF 000261
REF 000262
REF 000263
- 2 -
18F (6.0 mm) 1.2 cm
18F (6.0 mm) 1.7 cm
18F (6.0 mm) 2.4 cm
18F (6.0 mm) 3.4 cm
24F (8.0 mm) 1.2 cm
24F (8.0 mm) 1.7 cm
24F (8.0 mm) 2.4 cm
24F (8.0 mm) 3.4 cm
24F (8.0 mm) 4.4 cm
28F (9.3 mm) 1.5 cm
28F (9.3 mm) 2.7 cm
28F (9.3 mm) 4.3 cm