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Catalog Number RF310F |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was not provided, a lot history review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the alleged perforation of the ivc, filter tilt and retrieval difficulties.A definitive root cause for the reported event could not be determined.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model unknown g2 vena cava filter allegedly experienced difficult to remove, malposition of device and patient device interaction problem.This information was received from one source.The event involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.
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Manufacturer Narrative
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H10: the lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was not returned for evaluation, however, medical records were provided and reviewed.Therefore, the investigation is confirmed for the alleged filter tilt and retrieval difficulties, however, inconclusive for the alleged perforation of the inferior vena cava.A definitive root cause for the reported event could not be determined.The device is labeled for single use.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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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model rf310f vena cava filter allegedly experienced difficult to remove, malposition of device and perforation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The male patient is 63 years old whose weight was not provided.
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Search Alerts/Recalls
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