He information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reap0153 showed no other similar product complaint(s) from this lot number.
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The information provided by bard 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 bard.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a tear in the probe cover was confirmed, and the cause appears to be related to use of the device.One used probe cover was returned for investigation.The cover was crumpled and full of clear drops of fluid.Drops of a reddish colored fluid were observed in some areas within the probe cover, but the majority of fluid within the cover was clear.Three tears were observed in the distal (closed) end of the probe cover.The tears ranged from 4-6 mm in length.A microscopic examination of the tears revealed that the edges were uneven and jagged.A functional test revealed that fluid would leak from the three tears and from pinholes on each side of the probe cover near the distal end.It appears that the probe cover was snagged on the device it was covering or an external source.It was reported that the probe cover was used on a geiger counter hand piece (gamma probe), which was used during a breast node surgery.The product ifu states, ¿the site~rite* needle guides and probe cover kits are intended to be used with site~rite* ultrasound system probes.Site~rite* needle guide kits and probe cover kits provide a protective covering to sheath an ultrasound transducer and isolate a site of surgical penetration from microbial and other contamination.¿ the cause of the alleged blood residue inside the probe cover could be associated with the tears, due to the breach in the barrier.
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