Model Number 000259 |
Device Problems
Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889)
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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 for the reported malfunction; therefore, a lot history review is currently being performed.The device was not returned to the manufacturer for evaluation; however photo was provided.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 indicated that model 000259 feeding tube allegedly fluid leak and deformation due to compressive stress.This information was received from one source.One patient was involved with no reported patient injury.The device was used in a male patient.Age and weight of the patient was 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 000259 feeding tube allegedly had fluid leak and deformation due to compressive stress.This information was received from one source.One patient was involved with no reported patient injury.The device was used in a male patient.Age and weight 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 was performed.The device was not returned to the manufacturer for evaluation; however photos were provided and reviewed.Therefore, the investigation is inconclusive for the reported leak and deformation issues.A definitive root cause could not be determined based upon available information.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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