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Catalog Number MD800F |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Of the 3 devices, 2 lot numbers were provided, and lot history reviews were performed.Of the 3 reported malfunctions, no devices were returned for evaluation.Medical records were provided for 2 devices and reviewed for each malfunction.Filter tilt, retrieval difficulties and positioning issue were confirmed for 2 devices.1 device photo, x-ray image and medical records were provided.The photo, x-ray and medical record are currently underway review.The devices were labeled for single use.
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Event Description
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This report summarizes three malfunctions.A review of the reported information indicated that model md800f.Vena cava filter allegedly experienced difficult to remove, malposition of device and positioning issue.These reports were received from various sources.All three events involved a patient with no reported patient consequences.Of the three reported patient, three patients ranged from 50 ¿ 68 years of age, one patient weight was (b)(6) kgs and two were female and one was male; however, other patients weight was not provided.
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Manufacturer Narrative
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H10: of the 3 devices, 2 lot numbers were provided, and lot history reviews were performed.Of the 3 reported malfunctions, no devices were returned for evaluation.Medical records were provided for 3 devices and images were also provided for one malfunction.Filter tilt, retrieval difficulties and positioning issue were confirmed for 3 devices.A definitive root cause could not be determined.The devices are 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 three malfunctions.A review of the reported information indicated that model md800f.Vena cava filter allegedly experienced difficult to remove, malposition of device and positioning issue.These reports were received from various sources.All three events involved a patient with no reported patient consequences.Of the three reported patient, three patients ranged from 50 ¿ 68 years of age, one patient weight was 62kgs and two were female and one was male; however, other patients weight was not provided.
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Search Alerts/Recalls
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