ISOLATOR 1.5 ML MICROBIAL TUBES
Received Aug 2, 2011 · Event occurred Jun 28, 2011
Report 1221359-2011-00002 · MDR key 2214067
Device
Generic name
None
Lot number
031422
Product problems
- Break
- Fluid/Blood Leak
Patient
Not reported
- Exposure to Body Fluids
Narrative
Description of Event or Problem
CUSTOMER REPORTED ON (B)(6) 2011 THAT A BLOOD CULTURE TUBE SHATTERED WHEN INOCULATED WITH BLOOD ON (B)(6) 2011. BLOOD SPLATTERED OVER WALL AND 2 PEOPLE. NO OTHER INJURIES TO THE 2 PEOPLE INVOLVED DUE TO SHATTERING (GLASS DID NOT PUNCTURE SKIN).
Additional Manufacturer Narrative
LOT 031422 WAS MANUFACTURED ON 11/17/2010 AND CONSISTED OF (B)(4). (B)(4). THERE WAS ONE DEFECT NOTED FOR A BROKEN TUBE DURING THE ASSEMBLY OPERATION. NO TUBES WERE BROKEN DURING THE TESTING PROCESS. THERE WERE NO INTERNAL REJECTS ASSOCIATED WITH THIS LOT OF PRODUCTION. INVESTIGATION: NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE DEFECT COULD NOT BE CONFIRMED. IF A DEFECT CONDITION IS DETECTED, PRODUCT WOULD HAVE BEEN REJECTED AND DISPOSITIONED APPROPRIATELY. THIS IS THE ONLY EVENT OF THIS NATURE FOR THIS LOT.
Additional Manufacturer Narrative
LOT 031422 WAS MANUFACTURED ON 11/17/2010 AND CONSISTED OF (B)(4). (B)(4). THERE WAS ONE DEFECT NOTED FOR A BROKEN TUBE DURING THE ASSEMBLY OPERATION. NO TUBES WERE BROKEN DURING THE TESTING PROCESS. THERE WERE NO INTERNAL REJECTS ASSOCIATED WITH THIS LOT OF PRODUCTION. INVESTIGATION: NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE DEFECT COULD NOT BE CONFIRMED. IF A DEFECT CONDITION IS DETECTED, PRODUCT WOULD HAVE BEEN REJECTED AND DISPOSITIONED APPROPRIATELY. THIS IS THE ONLY EVENT OF THIS NATURE FOR THIS LOT.
Description of Event or Problem
CUSTOMER REPORTED ON (B)(6) 2011 THAT A BLOOD CULTURE TUBE SHATTERED WHEN INOCULATED WITH BLOOD ON (B)(6) 2011. BLOOD SPLATTERED OVER WALL AND 2 PEOPLE. NO OTHER INJURIES TO THE 2 PEOPLE INVOLVED DUE TO SHATTERING (GLASS DID NOT PUNCTURE SKIN).