SCRUB BRUSH E-Z SCRUB DRY STERILE

Additional Manufacturer Narrative

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-03-26. H.6. INVESTIGATION SUMMARY EIGHT PRIOR COMPLAINTS FOR FOREIGN MATTER IN THE PREVIOUS FIVE YEARS; HOWEVER NONE WERE FOR BURNT RESIN, WHICH IS THE ROOT CAUSE IN THIS CASE DHR REVIEWED. NOTHING RELATED TO FOREIGN MATTER IS NOTED. ONE SAMPLE RECEIVED. PACKAGE OPENED, DECONTAMINATED AND IN GOOD CONDITION. BRUSH SIDE SHOWS THE TIPS OF THREE TINES WERE DARKENED. THERE WAS ALSO A DARK SPOT BETWEEN THE SPONGE AND THE BRUSH APPROXIMATELY 4 MM IN DIAMETER, THAT WAS VISIBLE THROUGH THE BRUSH MATERIAL. EXAMINATION OF THE RETURNED SAMPLE WAS CONDUCTED WITH A LOW POWER EXAMINATION MICROSCOPE. THE DIRT APPEARS TO BE EMBEDDED BURNT RESIN FROM THE BRUSH. EXCESS HEAT DURING THE MOLDING PROCESS CAUSES THE RESIN TO BURN. THIS LIKELY OCCURRED BECAUSE A SMALL PIECE OF RESIN GOT CAUGHT UP IN THE PROCESS, LONG ENOUGH TO DISCOLOR. EIGHT PRIOR COMPLAINT FOR FOREIGN MATTER WERE REFERENCED EARLIER IN THE COMPLAINT HISTORY OVER THE LAST FIVE YEARS FOR DRY E-Z SCRUB PRODUCTS. THIS IS THE ONLY OTHER COMPLAINT FOR BURNT RESIN IN THE BRUSH FROM TWO YEARS AGO. PER RISK MANAGEMENT DOCUMENT (B)(4) THE SEVERITY OF THIS DEFECT IS CATEGORIZED AS NEGLIGIBLE (S1); THERE BEING NO POTENTIAL TO HARM THE PATIENT. THAT, COUPLED WITH AN OCCURRENCE RATE OF LESS THAN 1 OUT OF 1,000,000 UNITS CATEGORIZED AS IMPROBABLE (O1), EQUATES TO AN OVERALL RISK LEVEL OF LOW. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ALL COMPLAINTS ARE TRENDED AND REVIEWED AT MONTHLY QUALITY DATA ANALYSIS MEETINGS. THESE ARE CONDUCTED WITH MANUFACTURING AND MAINTENANCE ASSOCIATES, SURGICAL SCRUB STAFF AND AT THE INFECTION PREVENTION PLATFORM. IN ADDITION, ALL COMPLAINT DATA IS REVIEWED AT QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

Description of Event or Problem

IT WAS REPORTED THAT A SCRUB BRUSH E-Z SCRUB DRY STERILE PACKAGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRT INSIDE SCRUB PACKAGE. CUSTOMER OPENED PRODUCT AND DIRT/GRIT WAS INSIDE WITH THE SCRUB BRUSH AND IN BRISTLES."

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT A SCRUB BRUSH E-Z SCRUB DRY STERILE PACKAGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DIRT INSIDE SCRUB PACKAGE. CUSTOMER OPENED PRODUCT AND DIRT/GRIT WAS INSIDE WITH THE SCRUB BRUSH AND IN BRISTLES."