This is the second of three reports (same product id, same lot number, same problem, different occasions).Linked to manufacturing report numbers: 3006697299-2014-00116 and 3006697299-2014-00115.When the package was opened by the operating room staff inside the operating room, the part pops out.This results in the entire tubing set being unsterile and therefore unusable.The device was not in contact with a patient and there was no patient injury.The event did not lead to an increase in surgery time.Additional information received on (b)(6) 2014: it was clarified that there were 3 devices with packaging issues that occurred on three different occasions.The exact date of events were unknown.All three events happened during week 39 ((b)(6) 2014).There was no consequence for the patient.Patient age and gender, if the patient was under anesthesia when the issue occurred, and type of surgery were all unknown.The medical staff had to open a new package with another lot in order to finish/continue the procedure.It was reported that the problem was that the part pops when opening the package and the risk of unsterility.
|