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Catalog Number VC10118P |
Device Problems
Bent (1059); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No medical records or no medical images have been made available to the manufacturer.The device has been returned to the manufacturer for evaluation.As the lot number for the device was provided, a review of the device history records is currently being performed.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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Event Description
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It was reported that during a stereotactic breast biopsy, the coaxial cannula was allegedly bent inside the patient.It was further reported that there were enough samples to complete the procedure.Reportedly, the coaxial was unable to be used to guide the marker placement.There was no reported patient injury.
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Manufacturer Narrative
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After further review of the additional event details provided, the event suggests the device bent inside the patient.It was reported that the device allegedly bent and did not break.There was no reported patient injury.After reassessment of the information, this event was determined to be not mdr reportable.However, an initial mdr has already been submitted; therefore, the purpose of this supplemental report is to document the change in reportability classification.Section a through f - 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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Event Description
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It was reported that during a stereotactic breast biopsy, the coaxial cannula was allegedly bent inside the patient.It was further reported that there were enough samples to complete the procedure.Reportedly, the coaxial was unable to be used to guide the marker placement.There was no reported patient injury.
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Search Alerts/Recalls
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