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Catalog Number RF048F |
Device Problems
Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Activation Failure (3270)
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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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The lot number was not provided and a lot history review could not be performed.The device was not returned for evaluation; therefore the investigation is inconclusive for detachment of device or device component, activation failure including expansion failure, and patient-device incompatibility.Based on the available information, a definitive root cause could not be determined.The device is labeled for single use.(b)(4).
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Event Description
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This report summarizes 30 malfunctions.The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component (4), activation failure including expansion failure (12), and patient-device incompatibility (14).This information was received from one source.The malfunction involved all 30 patients with no patients¿ consequences.The age, weight, and gender were not provided.
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Manufacturer Narrative
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H10: the lot number was not provided and a lot history review could not be performed.The device was not returned for evaluation; therefore the investigation is inconclusive for the alleged malfunction.Based on the available information, a definitive root cause 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 30 malfunctions.The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component (4), activation failure including expansion failure (12), and patient-device incompatibility (14).This information was received from one source.The malfunction involved all 30 patients with no patients¿ consequences.The age, weight, and gender were not provided.
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Event Description
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This report summarizes 30 malfunctions.The information reviewed indicated that model rf048f vena cava filter allegedly experienced detachment of device or device component, activation failure including expansion failure, and perforation.This information was received from one source.The malfunction involved all 30 patients with no patients¿ consequences.The age, weight, and gender were not provided.
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Manufacturer Narrative
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H10: the lot numbers were not provided and a lot history reviews could not be performed.The devices were not returned for evaluation; therefore the investigation is inconclusive for all the alleged malfunctions.Based on the available information, a definitive root cause could not be determined.The devices are labeled for single use.Sanjeeva p kalva, christos a athanasoulis, chieh-min fan, marcio curvelo, stuart c geller, alan j greenfield, et al (2006).¿recovery¿ vena cava filter: experience in 96 patients.Cardiovasc intervent radiol, 29(4):559¿564.Doi: 10.1007/s00270-005-0271-1.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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Search Alerts/Recalls
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