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: per the lot history review, this is the first complaint reported for this lot number and issue to date.The quantity affected is one.Based upon the severity level and lot quantity, a dhr review is not required per (b)(4).Based on the manufacturing site: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the evaluation: one navarre locking pigtail 8 fr percutaneous biliary drainage catheter was returned for evaluation.Visual and functional evaluations were performed.The original cannula was not returned with the catheter sample so the investigation is inconclusive for the inner stylet not being able to be inserted into the pigtail, as the device functioned properly under laboratory conditions and the reported event could not be reproduced.The root cause for the inner stylet not being able to be inserted into the pigtail is inconclusive as the returned catheter had no apparent defects and functioned properly when interfaced with non-original samples.The original cannula sample was not returned.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.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.
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