Catalog Number 0620030407 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/08/2015 |
Event Type
malfunction
|
Event Description
|
It was reported that there was a piece of metal in the packaging.
|
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.
|
|
Manufacturer Narrative
|
The foreign material failure mode was confirmed on the unit returned.A small strand of wire was found inside the package.As per risk document most probable root causes are: 1.Manufacturing error; 2.Damage during shipment (inadequate packaging); 3.Damage during shipment (abuse during transit).The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that there was a piece of metal in the packaging.
|
|
Search Alerts/Recalls
|