|
Model Number FAF07070 |
Device Problems
Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
One device was returned for evaluation.The lot history review will be performed.The company is still investigating the issue at this time.The device is labeled for single use.
|
|
Event Description
|
This event summarizes one malfunction.The information reviewed indicated that model faf07070 endovascular stent graft allegedly experienced a break, detachment of device/device component, and difficult to remove.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient injury.
|
|
Event Description
|
This event summarizes one malfunction.The information reviewed indicated that model faf07070 endovascular stent graft allegedly experienced a break, detachment of device/device component, and difficult to remove.This report was received from one source.Age, weight, and gender were not provided for the patient.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: for the reported malfunction, a corporate lot number was provided and a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation identified the alleged break and detachment of device-device component but was inconclusive for difficult to remove.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
|
|
|