OtherFCE
CASE - 150ML SYRINGE W/HANDIFIL
Received Oct 3, 2007 · Event occurred Aug 6, 2007
Report 9610849-2007-00004 · MDR key 922586
Device
Product problems
- Foreign material
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Additional Manufacturer Narrative
PRODUCT SAMPLE STILL IN ROUTE FROM DISTRIBUTOR. ONCE PRODUCT HAS BEEN RECEIVED, AN INVESTIGATION WILL BE PERFORMED AND THE APPROPRIATE FOLLOW UP SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
DISTRIBUTOR REPORTS VIA E-MAIL THAT DURING INCOMING PRODUCT INSPECTION THE FOLLOWING DEFECT WAS DISCOVERED; "DUST WAS FOUND INSIDE HANDIFIL STRAW". SEARCH OF THIS LOT NUMBER AND PRODUCT ID REVEALS NO SIMILAR DESCRIPTIONS.