CARDINAL HEALTH

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

Description of Event or Problem

CUSTOMER REPORTED THAT DURING A CODE, THE PATIENT NEEDED TO BE CONTINUOUSLY SUCTIONED. WE WERE UNABLE TO EFFECTIVELY SUCTION THE PATIENT DUE TO A DEFECTIVE SUCTION YANKAUER DEVICE. THE TERMINAL END OF THE SUCTION DEVICE IS SEALED WHERE IT SHOULD BE OPEN IN ORDER TO EXTRACT THE FLUIDS. THE END HAD TO BE CUT OFF WITHOUT SUCCESS; THE PLASTIC TUBING HAD TO BE USED INEFFECTIVELY TO PROVIDE SOME TYPE OF SUCTIONING. PATIENT PASSED AWAY. DATE OF DEATH HAS NOT BEEN PROVIDED. AT THIS TIME, THE CUSTOMER HAS NOT CONFIRMED OR EXCLUDED CORRELATION BETWEEN THE DEVICE MALFUNCTION AND PATIENT¿S DEATH. NO FURTHER INFORMATION WAS PROVIDED.