Catalog Number 305959 |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2021 |
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 syringe 10ml ll package was damaged.This occurred on 9600 occasions.The following information was provided by the initial reporter: on delivery, the packages were broken and crushed, the packaging could no longer guarantee the sterility of the syringes.
|
|
Manufacturer Narrative
|
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2103052, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.The complaint could not be confirmed and the root cause is undetermined.
|
|
Event Description
|
It was reported that syringe 10ml ll package was damaged.This occurred on 9600 occasions.The following information was provided by the initial reporter: on delivery, the packages were broken and crushed, the packaging could no longer guarantee the sterility of the syringes.
|
|
Search Alerts/Recalls
|