Catalog Number MD800F |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)
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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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The lot number for the device was provided and a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.However, medical records were provided.The company is still investigating the issue at this time.The device was labeled for single use.(b)(4).
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model md800f vena cava filter allegedly experienced tilt, detachment, perforation and unable to retrieve.This information was received from one source.The malfunction involved patient with no known impact to the patient.The (b)(6) years old male patient's weight was unknown.
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Manufacturer Narrative
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H10: the lot number for the device was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, medical records were provided for review.The investigating is confirmed for perforation of the ivc and filter tilt; however, the investigating is inconclusive for unable to retrieve and detachment.Based upon the available information, the definitive root cause for this event is unknown.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 md800f vena cava filter allegedly experienced tilt, detachment, perforation and unable to retrieve.This information was received from one source.The malfunction involved patient with no known impact to the patient.The 66 years old male patient's weight was unknown.
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Search Alerts/Recalls
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