Model Number 001187-78 |
Device Problems
Fluid/Blood Leak (1250); Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problems
Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199); Inadequate Pain Relief (2388)
|
Event Date 10/05/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Event took place in (b)(6) and has been reported through (b)(4) distributor (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).Summarizing tentative translation from initial reporter's narrative: leakage at the hub.
|
|
Manufacturer Narrative
|
Event took place in (b)(6) and has been reported through (b)(4).Based on risk assessment and clinical evaluation file is considered as closed.
|
|
Event Description
|
(b)(4).Summarizing tentative translation from initial reporter´s narrative: leakage at the hub.
|
|
Search Alerts/Recalls
|