OtherGDM
HAWKINS III BLN
Received Jul 2, 2009 · Event occurred Apr 28, 2009
Report 1036710-2009-00010 · MDR key 1467911
Device
Generic name
Hawkins Iii Bln
Manufacturer
Angiotech, Medical Device Technologies, Inc.Model number
253100Catalog number
253100
Lot number
82741Q36
Product problems
- Unsealed Device Packaging
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
REPORT RECEIVED: THE POUCH WAS OPEN INSIDE OF THE BOX.
Additional Manufacturer Narrative
THE SAMPLES HAVE NOT BEEN RETURNED BY THE CUSTOMER TO CONFIRM THE DEFECT REPORTED. THIS CONDITION IS CAUSED WHEN A NEEDLE IS NOT FULLY IN THE POUCH AND RUNS THROUGH THE SEALER BARS. THE MISALIGNED BARS THEN REDUCE THE PRESSURE PLACED ON THE POUCH. THIS CONDITION HAS BEEN PREVENTED BY REFURBISHING THE MACHINES. THE DEFECT WAS ADDRESSED WITH THE PACKAGING DEPT BY THE PLANT MGR AND THE PRODUCTION MGR.