4C-ES CELL CONTROL
Received Jun 24, 2011 · Event occurred Jan 9, 2008
Report 1061932-2011-00687 · MDR key 2172318
Device
Product problems
- Crack
- Fluid/Blood Leak
- Low Test Results
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT LABELING STATES: "THIS SPECIMEN/REAGENT SHOULD BE HANDLED AT BIOSAFETY LEVEL 2, AS RECOMMENDED FOR ANY POTENTIALLY INFECTIOUS HUMAN SERUM OR BLOOD SPECIMEN IN THE CENTERS FOR DISEASE CONTROL/(B)(4) MANUAL "BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LABORATORIES, " 1988." THE FIELD SERVICE ENGINEER REPORTED USING THE ABNORMAL LOW CONTROL VIAL AT INITIAL OPENING OF THE VIAL TWO (2) DAYS PRIOR TO EVENT DATE AND VIALS WERE FINE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THEREFORE NOT AVAILABLE FOR EVALUATION. NO OTHER SIMILAR REPORTED EVENTS WITHIN THE PAST 12 MONTHS FOR THIS LOT NUMBER. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN THE ABNORMAL LOW CONTROL VIAL OF 4C -ES CELL CONTROL WAS LEAKING FROM A CRACK AT THE TOP OF THE VIAL. OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT. THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.