BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 7N8399 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The actual device was not available; however, a companion sample was received for evaluation.Visual inspection was performed which observed a packaging-damaged sterile packaging.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
During evaluation a one-link needle-free iv connector was returned with a damaged sterile packaging.This was observed prior to patient use.There was no patient involvement.No additional information is available.
|
|
Search Alerts/Recalls
|
|
|