The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿incorrect assembly operation¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following:
"instructions for use:
preparing for catheterization:
1.Open kit and remove contents.2.The gloves are not necessary to maintain aseptic
conditions during the procedure.The gloves are
for the operator's protection.Male/female catheterization:
1.Remove cap from insertion tip while squeezing
tabs.Save cap for closing the bag.2.Slide the catheter halfway into the insertion tip.3.Male - prepare the male urethral meatus and
the surrounding area with povidone-iodine
swabs provided.Female - prepare the female urethral meatus
by holding the outer labia apart and prep the
urethral meatus and surrounding area with
povidone iodine swabs provided.4.Male - holding the penis, advance the insertion
tip into the urethra no further than the flange base.Female - spread the inner labia, advance the
insertion tip into the urethra no further than the
flange base.Release the inner labia.5.Place your nondominant hand on the finger
control guide to stabilize catheter in urethra.With your dominant hand, grasp catheter
through bag approximately 1" below the finger
control guide and push catheter into urethra.The
catheter should be introduced by short, repetitive
pushing motions.Repeat motions until catheter
reaches bladder and urine starts to flow.6.Allow urine to flow freely, making certain the catheter
guide is elevated at least 4" above lower portion of the
bag.Allow flow until bladder is empty or until bag is filled.Precaution: it is recommended that the collection
bag be held.The catheter could possibly separate
from the collection bag when urine increases weight
of the bag.7.Withdraw the catheter from the urethra.Remove the
remaining portion of the catheter from the collection
bag by pulling it through the insertion tip.Note:
the catheter is designed to pass through the
insertion tip.8.The filled collection bag may be closed by replacing
the cap over the insertion tip.Make sure the cap snaps
on securely.Specimen collection:
to collect a specimen, obtain a sample cup/tube
and alcohol wipe.Remove guide tip by pulling tab(s)
upward from bag.Wipe port with alcohol.Pour
specimen through port at top of bag into cup/tube.Draining bag:
remove insertion tip by pulling tab(s) upward from
bag.Drain urine through port at top of bag."
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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