No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
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Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was required.The lot met all release criteria.Investigation summary: the device returned was one plastic navarre stylet.Four photographs were also returned, two of labeling and two of stylet piece(s).These photographs as a whole confirmed the product number to be nbd8 and the lot to be gfat2516.The breakage of the stylet into at least three pieces was confirmed from the photographs, as well as red and tan residues within the lumens.Visual observation found the stylet broken into 6 pieces, one with the luer attached.The pieces manifested residues.In several pieces, further bends were found which had not yet resulted in full breaks.Microscopic evaluation found the breaks to consist of partially brittle fractures, with significant evidence of bending and whitening juxtaposed.The two longest fully detached pieces were bent and found to fracture in a brittle manner.The complaint of a broken navarre stylet is confirmed.The brittleness of the stylet is related to the breakage of the stylet.The definitive root cause for the reported brittleness/breakage issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
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