Model Number 531157-32A |
Device Problems
Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Handling Problem (3265)
|
Patient Problems
Awareness during Anaesthesia (1707); No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
|
Event Date 05/19/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Event took place in (b)(6) and has been reported through (b)(4) distribution subsidiary (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).Tentative summarizing translation of initial reporter's narrative: upon advancement catheter kinks, hard to inject via kinked catheter, upon removal catheter tears apart, unable to handle this type of catheter.
|
|
Manufacturer Narrative
|
Based on risk assessment and clinical evaluation file is considered as closed.
|
|
Event Description
|
(b)(4).Tentative summarizing translation of initial reporter´s narrative: upon advancement catheter kinks, hard to inject via kinked catheter, upon removal catheter tears apart, unable to handle this type of catheter.
|
|
Search Alerts/Recalls
|