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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of huye1993 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (huye1993) have been reported from the same (b)(4) facility.Device not yet returned for evaluation.
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The following were reviewed as part of this investigation: patient severity, frequency 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 button replacement device was confirmed, but the exact cause could not be determined.The proximal end of a 24fr x 3.4cm button replacement device was returned for investigation.There was a complete tear in the button shaft at the distal surface of the external bolster.The shaft and button dome were not returned for investigation.A microscopic examination of the button shaft revealed that approximately one quarter of the cross section exhibited what appear to be beach marks that originated from the side with the strap and plug.It appears that the tear developed over time.The remainder of the cross section was uneven, but smooth and granular.At this time, based on the condition of the returned sample, it appears that the damage occurred during use, but the exact mechanism of damage could not be determined.Potential contributing factors include tension on the external bolster exceeds material strength.
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