Model Number 0331152-51 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Fracture (1260); Product Quality Problem (1506)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/01/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Event took place in (b)(6) and has been reported through (b)(4).Currently the data is poor and the device has not been sent back/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.
|
|
Event Description
|
(b)(4).Reporter's narrative: the administration of the anaesthetic through the epidural catheter was impossible because of the leakage of drug from the distal connection of the filter.In order to solve the problem, the set was replaced by another epilong set.
|
|
Manufacturer Narrative
|
Based on risk assessment and clinical evaluation file is considered as closed.
|
|
Event Description
|
(b)(4).Reporter´s narrative: the administration of the anaesthetic through the epidural catheter was impossible because of the leakage of drug from the distal connection of the filter.In order to solve the problem, the set was replaced by another epilong set.
|
|
Search Alerts/Recalls
|