Model Number 9808560 |
Device Problems
Reflux within Device (1522); Obstruction of Flow (2423)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The lot number was not provided; therefore, a lot history review could not be performed.The sample was returned and the investigation is currently underway for the reported event.The device was labeled for single use.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 9808560 implantable port allegedly experienced catheter occlusion.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 9808560 implantable port allegedly experienced catheter occlusion.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
|
|
Manufacturer Narrative
|
H10: the lot number was provided; therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation/inspection.The investigation is inconclusive for the occlusion issue.Based on the available information, the 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.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model 9808560 implantable port allegedly experienced catheter occlusion and reflux within the device.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
|
|
Manufacturer Narrative
|
H10: the lot number was not provided for the reported malfunction; therefore, a lot history review will not be performed.The device was returned to the manufacturer for evaluation/inspection.The investigation is inconclusive for the occlusion and reflux within the device issue.Based on the available information, the 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.
|
|
Search Alerts/Recalls
|