Catalog Number 515008 |
Device Problem
Difficult or Delayed Activation (2577)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/23/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that injector luer lock n35j was disengaged with the needle exposed.The following information was provided by the initial reporter: the customer reported that the injector was disengaged with the needle exposed.The drug used is an anticancer agent with the name unknown.
|
|
Event Description
|
It was reported that injector luer lock n35j was disengaged with the needle exposed.The following information was provided by the initial reporter: the customer reported that the injector was disengaged with the needle exposed.The drug used is an anticancer agent with the name unknown.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-08.H6: investigation summary one sample was submitted to our quality team for investigation.Through visual inspection, it is noted that the injector needle is exposed and the injector handles are displaced from their original location.The product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.The dhr of lot 2009007 involved is reviewed without finding any deviations or non-conformance to the reported defect.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.It appears that this incident was due to excessive force during connection/disconnection of the device.
|
|
Search Alerts/Recalls
|