Catalog Number 0250070620 |
Device Problems
Contamination (1120); Contamination /Decontamination Problem (2895)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/12/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.
|
|
Event Description
|
It was reported that foreign materials were found inside the sterile packaging.
|
|
Manufacturer Narrative
|
Alleged failure: it was reported by the sales rep adam lotz the packaging had contaminants ref rma (b)(4) salesforce case number 08335473.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be the tyvek cover was dirty or the packagers hand had contaminants during packaging.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that foreign materials were found inside the sterile packaging.
|
|
Search Alerts/Recalls
|