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Patient 1
THE COMPLAINT CALL STATES THAT THE "COLLAR CRACKED UNDER CHIN." THE COMPLAINT CALL DID NOT SPECIFY IF THE COLLAR WAS BROKEN DURING APPLICATION ON A PATIENT. THE ISSUE WAS REPORTED AS BEING IDENTIFIED WHILE STILL IN THE PACKAGE. THE SAMPLE WAS RECEIVED BY QC MANAGER BASED ON PICTURE ATTACHED TO THE CALL, COLLAR WAS INDEED CRACKED UNDER CHIN. DEVICE HISTORY RECORD (DHR) OF THE WORK ORDER (B)(4) PROVIDED WITH THE CALL AND WORK ORDER SUBASSEMBLY AND THE SET UP SHEETS, WERE REVIEWED NO DISCREPANCIES COULD BE FOUND. THIS PART IS MOLDED FROM POLYPROPYLENE (PP) RESIN. QC MANAGER IN CONJUNCTION WITH MOLDING SUPERVISOR AND MOLDING TECHNICIAN EVALUATED THE PICTURES ATTACHED TO THE CALL. WHILE EVALUATING THE SECTION WHERE THE CRACKED OCCURRED, FROM MOLDING SUPERVISOR PERSPECTIVE, THIS AREA COULD BE IMPROVE BY REINFORCING IT AND ADDING MORE PLASTIC, THIS WILL GIVE MORE STRENGTH AND ROBUSTNESS TO THIS AREA. PPF0302C MOLDING WILL BE SENT TO THE RESPONSIBLE PERSONNEL TO MAKE THE NECESSARY IMPROVEMENTS. A CORRECTIVE AND PREVENTIVE ACTION REPORT (B)(4) INVESTIGATION WAS PERFORMED FOR SIMILAR COMPLAINTS IN 2015. AS A RESULT, THE POLYPROPYLENE (PP) RESIN RAW MATERIAL WAS CHANGED TO IMPROVE THE ELASTICITY OF THIS PART. THE FIRST LOT OF THIS PRODUCT THAT INCORPORATED MOLDED PIECES WITH THIS NEW POLYPROPYLENE RESIN WAS MANUFACTURED ON 01/27/2016 (LOT 41545015). IT WAS CONFIRMED THAT THE WORK ORDER PROVIDED WITHIN THE CALL WAS MANUFACTURED AFTER THE IMPROVEMENT. ALTHOUGH THE BREAKAGES ARE OCCURRING, THE AMOUNTS OF COMPLAINTS RECEIVED DUE TO THIS CONDITION HAVE BEEN REDUCED. AS OF 03/22/2017, ONLY 4 COMPLAINTS THAT CALL FOR THIS TYPE OF FAILURE HAS BEEN RECEIVED, FOR PRODUCT MANUFACTURED AFTER THE PREVIOUS CORRECTIVE ACTION, WAS IMPLEMENTED. ALTHOUGH, AT THIS TIME, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AFTER EXAMINING ALL AVAILABLE INFORMATION (FINISHED GOOD WORK ORDER, SUB-ASSEMBLY AND MOLDING SET UP SHEET). WITH THE CONCLUSION ABOUT THE MEETING HELD WITH MOLDING SUPERVISOR AND HIS INPUTS ABOUT THE CRACKING ISSUE, A POTENTIAL ROOT CAUSE COULD BE BASED ON PIECE DESIGN AND HIS EXPERIENCE, THIS SECTION COULD ALLOW A WEAKNESS THAT MAY LEAD TO THE WHOLE MIDDLE SECTION CRACKING. AS CORRECTIVE ACTION ANOTHER IMPROVEMENT WILL BE MADE TO THE MOLD BY ADDING MORE PLASTIC TO THE MIDDLE SECTION. THIS WILL GIVE MORE STRENGTH AND ROBUSTNESS TO THIS AREA. THE PLANNED COMPLETION DATES FOR THIS IMPROVEMENT, TO BE MADE TO THE MOLD, IS SET TO THE 16/JUN/2017. BETWEEN, JANUARY 1, 2015 - MARCH 27, 2017, THERE HAVE BEEN A TOTAL OF 22 COLLARS REPORTED TO BE MALFUNCTIONING AND (B)(4) UNITS SOLD, OF THIS PRODUCT 1044-31 CERVICAL COLLAR, EMT SELECT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE A FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.