Model Number 9808560 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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For the reported event, lot number was provided, and lot history review.The sample was returned 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 indicated that model 9808560.Implantable port allegedly experience device contamination with chemical or other material.This report was received from a single source.This event did not involve patient with no patient contact.Age, weight, and gender were not provided for the patient.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model 9808560.Implantable port allegedly experienced device contamination with chemical or other material.This report was received from a single source.This malfunction did not involve a patient.Age, weight, and gender were not provided.
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Manufacturer Narrative
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H10: the lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has been returned for evaluation; the evaluation was inconclusive for 2944 - device contamination with chemical or other material.Based upon the available information, a definitive root cause 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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Search Alerts/Recalls
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