Model Number 0254513 |
Device Problem
Material Rupture (1546)
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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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As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; therefore, the investigation is inconclusive for material rupture.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 0254513 pta dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction 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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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 0254513 pta dilatation catheter allegedly experienced material rupture.This information was received from one source.The malfunction 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 reported malfunction was reassessed for reportability and determined to be no longer reportable.H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; therefore, the investigation is inconclusive for material rupture.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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Search Alerts/Recalls
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