Model Number 1185-3E080 |
Device Problems
Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); No Flow (2991)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/14/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Event took place in the (b)(6) and has been reported through (b)(4) subsidiary pajunk (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
|
Internal report number: (b)(4).User's narrative: blockage.Unable to prime with saline before use.
|
|
Manufacturer Narrative
|
Based on risk assessment and clinical evaluation file is considered as closed.
|
|
Event Description
|
(b)(4).User´s narrative: blockage.Unable to prime with saline before use.
|
|
Search Alerts/Recalls
|