No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned 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 required.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 senomark ultra marker applicator and two electronic photos were provided for evaluation.Based on the photo review, one partial encor probe cannula with marker applicator visible in the aperture, one partial marker plunger rod without the applicator, and one partial marker applicator with a plunger rod inserted can be seen laying on a flat surface.Approximately 5in.Of each distal end of the devices are visible in the photos.During evaluation of the returned marker applicator, it was noted the plunger rod was received in the fully advanced position, the distal end of the applicator was detached and returned within the probe used in the event.The detached portion of the applicator contained one pga pad and wireform.The push rod was also noted to have a detached and damaged distal end.Therefore, based on the returned sample condition, the investigation is confirmed for the reported deployment failure, removal difficulty, and detachment.The investigation is inconclusive for the reported insertion difficulties as the device was unable to be functionally tested with the returned probe.Per the reported event details, "excessive force was required to depress the plunger".Although it is likely the excessive force used contributed to the reported deployment failure and remove issues, the definitive root cause for the reported 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.
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