Model Number 9808560 |
Device Problems
Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Suction Problem (2170)
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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 for the reported malfunction was provided, therefore, a lot history review is currently being performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is identified for the reported leak issue.The definitive root cause 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 9808560 implantable port allegedly experienced subcutaneous leak.This information was received from one source.One patient was involved with no reported patient injury.Age, gender 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 9808560 implantable port allegedly experienced subcutaneous leak.This information was received from one source.One patient was involved with no reported patient injury.Age, gender and weight of the patient was not provided.
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a lot history review could not be performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for catheter burst and leak.Based upon the available information, the definitive root cause 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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