The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to "adhesive chemistry not appropriate for application (poor quick stick characteristics)".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following:
"statlock® foley stabilization device
read carefully before use.Safety and efficacy considerations:
single use.Do not alter the statlock® device or components.Procedure must be performed
by trained personnel with knowledge of anatomical landmarks, safe technique
and potential complications.Contents: package includes the statlock® device stabilization system and
skin preparation pad.Indications for use:
the statlock® device is a stabilization device for compatible catheters.Contraindications:
known tape or adhesive allergies.Warnings and precautions:
1.Do not use the statlock® device where loss of adherence could occur, such
as with a confused patient, diaphoretic or non-adherent skin, or when the
access device is not monitored daily.2.Observe universal blood and body fluid precautions and infection control
procedures, during application and removal of the statlock® device.3.Minimize catheter manipulation during application and removal of the
statlock® device.4.Daily maintenance:
a.The statlock® device should be assessed daily and changed when
clinically indicated, at least every seven days.B.If pad becomes soiled, wash with soap/water, saline or hydrogen peroxide.Do not use alcohol or prepackaged bathing systems, which could lead to
early lifting.C.If showering/bathing, cover with plastic wrap or waterproof dressing.D.Conduct skin assessment prior to application and repeat daily per
facility protocol.E.Use clinical judgment on the removal of the statlock® stabilization device if
the patient experiences any fluid shifts that may interfere with skin integrity.The statlock® stabilization device should be monitored daily and replaced when
clinically indicated, at least every 7 days.The catheter insertion site should be treated
per local policy recommendations.The statlock® device is contraindicated on patients
with known tape and adhesive allergies.Alcohol and acetone may weaken the adhesive
bond between the statlock® device pad and the skin.Care should be taken when using
these solutions while performing catheter site care.Please consult product inserts and
labels for any indications, contraindications, hazards, warnings, cautions and directions
for use.For additional information on the statlock® foley stabilization device, please
call your local bard representative.Instructions for use
foley
application technique
prep
1.Place foley catheter into retainer.Directional arrow should point towards catheter tip,
and balloon inflation arm should be next to the clamp hinge.2.Close lid, being careful to avoid pinching the catheter.3.Identify securement site by laying the device retainer on the front of the thigh, leaving
1 inch of catheter slack between insertion site and the statlock® device retainer.4.After placing the statlock® stabilization device off to the side, cleanse and
degrease the securement site with alcohol per hospital policy.Let skin dry.5.Apply skin protectant, in direction of hair growth, to area larger than securement site.Allow to dry completely (10-15 seconds).6.Using permanent marker, write initials and date of application on the statlock®
device anchor pad.Note: always secure catheter into the statlock® device retainer before applying
adhesive pad on skin.Place and peel
7.Align the statlock® stabilization device over securement site leaving 1 inch of
catheter slack.Make sure leg is fully extended.8.While holding the retainer to keep the pad in place, peel away paper backing, one
side at a time and place tension-free on skin.Removal technique
disengage
1.Open retainer by pressing release button with thumb, then lift to open.2.Remove foley catheter from the statlock® device.Dissolve
3.Wipe the edge of the pad using at least 5-6 alcohol pads until a corner lifts.Then
continue to stroke undersurface of pad with alcohol to dissolve adhesive pad away
from skin.Do not pull or force pad to remove."
h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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