MalfunctionEFS
STRYKEFLOW2 WITHOUT TIP (6BX)
Received Nov 30, 2007 · Event occurred Nov 1, 2007
Report 2648666-2007-00081 · MDR key 956755
Device
Generic name
Tubing
Manufacturer
Stryker Endoscopy Puerto RicoCatalog number
0250070500
Lot number
07288FG2
Product problems
- Unsealed Device Packaging
- Sterility
- Out-Of-Box Failure
Patient
UNK YR
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE PACKAGE WAS OPENED 1 OUT OF 6 PRODUCTS IN THE BOX WAS NOT PACKAGED PROPERLY AND THEREFORE UNSTERILE AND NOT USABLE.
Additional Manufacturer Narrative
ADD'L INFO WILL BE PROVIDED WHEN INVESTIGATIN IS COMPLETED.