H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.The medical records allege inferior vena cava filter was implanted for a patient.The inferior vena cavogram confirmed appropriate placement of the filter.There were no immediate complications.Approximately one month later, the patient reported to the hospital for abdominal pain.An ultrasound was performed, and the inferior vena cava filter was identified with no definite clots.However, on the same day, the filter was had shown migration and was retrieved.Therefore, the investigation is confirmed for the alleged filter migration.The definitive root cause could not be determined based upon available 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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