4C PLUS COULTER CELL CONTROL
Received Jul 1, 2011 · Event occurred Mar 17, 2008
Report 1061932-2011-00772 · MDR key 2171360
Device
Product problems
- Fluid/Blood Leak
- Loose or Intermittent Connection
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE OTHER TWO CONTROL LEVELS WITHIN THE KIT DID NOT EXHIBIT THIS ISSUE. THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THEREFORE NOT AVAILABLE FOR EVAL. THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR LEAKING VIALS UPON RECEIPT FOR 4C PLUS COULTER CELL CONTROL WITHIN THE PAST 12 MONTHS. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.
Description of Event or Problem
CUSTOMER REPORTED A POTENTIAL BIOHAZARD WHEN USING THE 4C PLUS COULTER CELL CONTROL. CUSTOMER REPORTED THAT UPON RECEIPT, THE ABNORMAL HIGH VIAL HAD LEAKED DUE TO A LOOSE CAP. OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.