Of the 2 devices, 2 lot numbers were provided, and lot history reviews were performed.Of the 2 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for both malfunctions.For one malfunction, the investigation is confirmed for difficult to remove and malposition of device.For another malfunction, investigation is confirmed for difficult to remove; however, the investigation is inconclusive for malposition of device.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.
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This report summarizes two malfunctions.A review of the reported information indicates that model dl900j vena cava filter allegedly experienced difficult to remove and malposition of device.The information was received from various sources.Of the two malfunctions, both involved patients with no patient consequences.Two female¿s ages were reported ranging from 33 to 65; however, the weights were not reported for both patients.
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