H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one x-ray centered around the right lower chest was reviewed.An object resembling an ivc filter leg is visualized in the right lung field.The inferior vena cava filter is not visualized in the provided image.Based on the image review the reported filter limb detachment can be confirmed.Three electronic photos were reviewed.Photo one shows the top portion of the filter.Photo two shows the filter in deployed position.It was observed that one of the filter arm was found to be missing in both the photos.Blood residue was noted on the arms and legs.The third photo shows the patient details.Based on the photo review, the reported filter limb detachment can be confirmed.One denali filter was returned for evaluation.The filter was received in a specimen cup in a deployed position.Blood residue was noted on arms and legs.One of the filter arm was found to be missing.Therefore, based on the provided photo and image review and the returned sample evaluation, the investigation is confirmed for the filter limb detachment.A definitive root cause for the reported filter limb detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: 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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