Catalog Number 07.02015.008 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/23/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
|
|
Event Description
|
It was reported a package labeled as a 55m rod actually contained a 50mm rod.This was identified at the warehouse.
|
|
Manufacturer Narrative
|
Udi number: (b)(4).Additional information: (method, results, conclusions) - the returned rod was evaluated.A review of the manufacturing records determined that the length of the rod matched the part number etched on the rod, and also matched the part number and description on the package label; however, the length etched on the rod is incorrect.It was etched as 50mm instead of the correct length of 55mm.The cause is attributed to a manufacturing error during the etching process.
|
|
Event Description
|
It was reported a package labeled as a 55m rod actually contained a 50mm rod.This was identified at the warehouse.
|
|
Search Alerts/Recalls
|