Model Number 40S05C |
Device Problem
Patient Device Interaction Problem (4001)
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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 provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.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 40s05c eptee vascular graft allegedly patient device interaction problem.This information was received from one source.The alleged malfunction had patient involvement but there were no reported patient consequences.The age, weight and gender of the patient was not provided.
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Manufacturer Narrative
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H10: the lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g3.H11: b5, d4.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 cf40a74c eptee vascular graft allegedly patient device interaction problem.This information was received from one source.The alleged malfunction had patient involvement but there were no reported patient consequences.The age, weight and gender of the patient was not provided.
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Search Alerts/Recalls
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