Model Number FEM09060 |
Device Problems
Positioning Failure (1158); Material Perforation (2205)
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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 was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.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 indicates that model fem09060 endovascular stent graft experienced a positioning failure and material perforation.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The (b)(6) year old female patient weighed (b)(6) lbs.
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Manufacturer Narrative
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H10: h10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is 03/31/2020.H10: the lot number was provided; therefore, a device history review was performed.The sample was returned to bd for evaluation and the alleged malfunction was confirmed.A definite root cause for the reported event could not be determined.The device is labeled for single use h10: g4 h11: g1,h6 (result, conclusion) 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 indicates that model fem09060 endovascular stent graft experienced a positioning failure and material perforation.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 62 year old female patient weighed 232 lbs.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicates that model fem09060 endovascular stent graft experienced a positioning failure and material perforation.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 62 year old female patient weighed 232 lbs.
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Manufacturer Narrative
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The initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is 03/31/2020.The lot number was provided; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.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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