No medical records or no 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.(b)(4).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 not required.However requested.The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one partial senomark ultra marker applicator was returned for evaluation.The returned marker applicator was received severely stretched with the distal end detached.The detached segment was not returned for evaluation.No marker pga pads or wireform were returned for evaluation.Therefore, the investigation is confirmed for the reported removal issues and identified detachment, due to the returned sample condition (e.G., sever stretching and detached segment).Additionally, the investigation is inconclusive for the reported failure to deploy issue and bent applicator.Per the reported event details, before use, the marker appeared bent upon opening.It is highly likely user related issues (e.G., use of damaged marker) contributed to the reported deployment failure and it is likely the reported removal difficulties contributed to the identified detachment.However, the definitive root cause for the reported and identified failures could not be determined based upon the provided information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Section a through f - 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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