BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 7N8399 |
Device Problems
Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that an unspecified quantity of one-link needle-free iv connectors had connection issues with syringes resulting in radioactive isotope leakage; the connections were not stable.This was identified during unspecified process steps.The threads of the devices did not match up with a firm connection.Decontamination and replacement of the isotope was performed to continue treatments.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The events occurred on unspecified dates, including "last week".The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Manufacturer Narrative
|
Additional information: d10, h10.D10: update "syringes" to "cardinal syringes".H10: should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|