INTL QCARE Q4 SYS W/CORINZ 20

Additional Manufacturer Narrative

THE COMPLAINANT DID NOT RETURN THE AFFECTED DEVICE FOR EVALUATION, NOR PROVIDE PHOTOGRAPHS OF THE SWAB TO AID IN THE INVESTIGATION. HOWEVER, THEY DID RETURN SAMPLE PRODUCT FROM THE SAME LOT. TWENTY KITS FROM THE AFFECTED LOT WERE RETURNED. THE KITS WERE OPENED, AND THE SUCTION SWABS WERE INSPECTED FROM EACH KIT. ALL THE SWABS APPEARED INTACT AND FREE OF ANY MANUFACTURING DEFECTS. A PRODUCT HISTORY REVIEW WAS PERFORMED FOR THE AFFECTED FINISHED GOOD AND LOT NUMBER. IN-PROCESS CHECKS ARE PERFORMED EVERY TWO HOURS DURING MANUFACTURING OF THE FINISHED PRODUCT. THE REVIEW REVEALED THAT ALL IN-PROCESS QUALITY CHECKS, EXCEPT ONE, PASSED DURING THE PRODUCTION OF THE AFFECTED LOTS. A PRODUCTION RECORD REVIEW REVEALED THAT THE REASON FOR THE FAILED IN-PROCESS QUALITY CHECK WAS "DAMAGED STRAWS". A 100% INSPECTION OF ALL SUSPECT MATERIAL WAS PERFORMED. ALL PRODUCT THAT WAS FOUND TO BE NONCONFORMING DURING THE INSPECTION WAS REJECTED. SINCE THE COMPLAINANT STATED THAT THE PATIENT BIT DOWN ON THE SWAB CAUSING THE DISENGAGEMENT, THE ROOT CAUSE IS RELATED TO USER ERROR/CUSTOMER MISUSE. COMPLAINTS RELATED TO SUCTION SWAB DISENGAGEMENT DUE TO BITING WILL CONTINUE TO BE MONITORED AND TRENDED.

Description of Event or Problem

NO ADDITIONAL EVENT INFORMATION HAS BEEN RECEIVED.

Description of Event or Problem

REPORT RECEIVED OF A DISENGAGEMENT RELATED TO USER ERROR. REPORTEDLY, STAFF WAS PERFORMING ORAL CARE WITH A SUCTION SWAB ON A PATIENT OF UNKNOWN AGE AND GENDER ADMITTED FOR A SPINAL CORD INJURY. REPORTER STATED SHE WAS CLEANING THE PATIENT'S TONGUE FOR ABOUT THIRTY SECONDS WITH THE DEVICE, WHEN THE PATIENT BIT DOWN ON THE DEVICE, AND THE FOAM AND A PIECE OF THE SUCTION STRAW (AROUND THE SUCTION HOLE) DISENGAGED IN THE PATIENT'S MOUTH. REPORTER STATED THIS EVENT OCCURRED WITH THE INITIAL USE OF THE DEVICE. STAFF WERE ABLE TO REMOVE THE DISENGAGED FOAM AND SUCTION STRAW WITHOUT DIFFICULTY. PATIENT WAS SEDATED, DROWSY, AND UNABLE TO FOLLOW COMMANDS. A BITE BLOCK WAS NOT IN USE AT THE TIME OF THE DISENGAGEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. LOT INFORMATION WAS PROVIDED. THE AFFECTED DEVICE WAS DISCARDED. AWAITING RETURN OF SAMPLES FROM THE SAME LOT AS THE AFFECTED DEVICE.