FLEXI-TIP ROSE

Description of Event or Problem

THIS SPONTANEOUS DEVICE REPORT WAS RECEIVED BY BRACCO IMAGING SCANDINAVIA FROM A HEALTH PROFESSIONAL ON 20-AUG-2019, FORWARDED TO TFS ON 21-AUG-2019 AND SENT TO BRACCO (B)(4) ON 22-AUG-2019. THE PATIENT IS UNKNOWN (NO IDENTIFIERS PROVIDED). WITH THE FOLLOW-UP INFORMATION DATED 11-SEP-2019, THE CASE BECAME VALID (PATIENT IS AN (B)(6) YEAR-OLD MALE). CASE DESCRIBES THE OCCURRENCE OF A DEVICE COMPONENT MALFUNCTION AND DISLOCATION, CAUSING A SITE INJURY AND REQUIRING A SURGICAL REMOVAL OF FOREIGN BODY FROM RECTUM IN A (B)(6)-YEAR-OLD MALE PATIENT WHO UNDERWENT A COLON EXAMINATION DUE TO AN UNKNOWN INDICATION WITH AN UNSPECIFIED BARIUM (UNKNOWN TRADE NAME). PATIENT'S PAST MEDICAL HISTORY WAS UNKNOWN. CONCOMITANT ILLNESS AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2019 THE PATIENT UNDERWENT A COLON EXAMINATION WITH UNSPECIFIED BARIUM ADMINISTERED BY A FLEXI TIP ROSE (ITEM 650097). THE FLEXI TIP ROSE HAD A DEFECT ON THE PART THAT CONNECTS IT TO THE TUBE. DUE TO THE DEFECT, DURING THE EXAMINATION, THE FLEXI TIP ROSE WAS SEPARATED FROM THE TUBE AND IT WENT INTO THE RECTUM OF THE PATIENT. THE DEFECT PRODUCT WAS REMOVED FROM THE PATIENT'S RECTUM BY THE SURGEON AT THE HOSPITAL WITH A RECTOSCOPE. THE COMPLAINANT DID NOT REMEMBER IF THE PATIENT WAS SENT TO THE SURGEON, OR IF THE SURGEON CAME TO THE RADIOLOGY DEPARTMENT AND REMOVED IT THERE. ONCE REMOVED, THE PATIENT HAD TO BE EXAMINED ONE MORE TIME. THE PATIENT RECOVERED WITHOUT SEQUELAE FROM THE EVENTS. THE REPORTER SPECIFIED THAT 7 OUT OF 24 UNITS WERE DEFECTIVE. MOST RECENT FOLLOW-UP INFORMATION RECEIVED BY BRACCO IMAGING SCANDINAVIA/TFS FROM THE REPORTER ON 11-SEP-2019 AND SENT TO BRACCO (B)(4) ON THE SAME DAY, INCORPORATED ABOVE, INCLUDES: PATIENT'S DETAILS AND DATE OF INCIDENT. WITH FOLLOW-UP INFORMATION THE CASE BECAME VALID. OUTCOME: RECOVERED. ADDITIONAL INFORMATION IS REQUIRED.

Description of Event or Problem

THIS SPONTANEOUS DEVICE REPORT WAS RECEIVED BY BRACCO IMAGING SCANDINAVIA FROM A HEALTH PROFESSIONAL ON 20-AUG-2019, FORWARDED TO TFS ON 21-AUG-2019 AND SENT TO BRACCO MILAN ON 22-AUG-2019. THE PATIENT IS UNKNOWN (NO IDENTIFIERS PROVIDED). WITH THE FOLLOW-UP INFORMATION DATED 11-SEP-2019, THE CASE BECAME VALID (PATIENT IS AN 83 YEAR-OLD MALE). CASE DESCRIBES THE OCCURRENCE OF A DEVICE COMPONENT MALFUNCTION AND DISLOCATION, CAUSING A SITE INJURY AND REQUIRING A SURGICAL REMOVAL OF FOREIGN BODY FROM RECTUM IN A 83-YEAR-OLD MALE PATIENT WHO UNDERWENT A COLON EXAMINATION DUE TO AN UNKNOWN INDICATION WITH AN UNSPECIFIED BARIUM (UNKNOWN TRADE NAME). PATIENT'S PAST MEDICAL HISTORY WAS UNKNOWN. CONCOMITANT ILLNESS AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2019 THE PATIENT UNDERWENT A COLON EXAMINATION WITH UNSPECIFIED BARIUM ADMINISTERED BY A FLEXI TIP ROSE (ITEM 650097). THE FLEXI TIP ROSE HAD A DEFECT ON THE PART THAT CONNECTS IT TO THE TUBE. DUE TO THE DEFECT, DURING THE EXAMINATION, THE FLEXI TIP ROSE WAS SEPARATED FROM THE TUBE AND IT WENT INTO THE RECTUM OF THE PATIENT. THE DEFECT PRODUCT WAS REMOVED FROM THE PATIENT'S RECTUM BY THE SURGEON AT THE HOSPITAL WITH A RECTOSCOPE. THE COMPLAINANT DID NOT REMEMBER IF THE PATIENT WAS SENT TO THE SURGEON, OR IF THE SURGEON CAME TO THE RADIOLOGY DEPARTMENT AND REMOVED IT THERE. ONCE REMOVED, THE PATIENT HAD TO BE EXAMINED ONE MORE TIME. THE PATIENT RECOVERED WITHOUT SEQUELAE FROM THE EVENTS. THE REPORTER SPECIFIED THAT 7 OUT OF 24 UNITS WERE DEFECTIVE. QUALITY RESULTS HAVE BEEN PROVIDED BY BRACCO GROUP QUALITY: THE SUPPLIER PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FINISHED GOODS LOT NO. 60012452. THERE WERE NO NON-CONFORMANCES OR DEVIATIONS RELATED TO THE REPORTED COMPLAINT. ALL PRODUCTS INVOLVED WERE MANUFACTURED UNDER THE REQUIRED SPECIFICATION CRITERIA. ALL LINE CLEARANCE REPORTS, INSPECTION REPORTS, AND PRODUCTION RUN REPORTS THAT WERE COMPLETED DURING THE PRODUCTION RUNS WERE DOCUMENTED AS ACCEPTABLE. IN ADDITION, AN INSPECTION OF THE COMPONENT PARTS (FLEXI TIP AND CONNECTOR "TYPE S") SHOWED NO ISSUES FOR THE INVOLVED LOTS ACCORDING TO THE RAW MATERIAL INSPECTION REPORT. SEVEN (7) SAMPLES WERE RETURNED FROM THE CUSTOMER. AN EVALUATION OF THE SAMPLES CONFIRMED THE CONNECTOR ON ALL 7 SAMPLES WAS DETACHED FROM THE ENEMA TIP. ACCORDING TO RESULTS OF THE INVESTIGATION PERFORMED REGARDING THIS MATTER; AN INCORRECT LUBRICATION OF THE TIP IS THE MOST FEASIBLE CAUSE THAT COULD HAVE CONTRIBUTED TO THIS DEFECT. A CORRECTIVE ACTION WAS SUBSEQUENTLY PROPOSED AND IMPLEMENTED TO PERFORM A VERIFICATION OF THE FINAL ASSEMBLY FOR THE BONDING OF THE "S" TYPE CONNECTOR IN ORDER TO INCREASE DETECTABILITY OF THIS FAILURE MODE. BASED ON THE SUPPLIER'S ANALYSIS IT WAS CONFIRMED THAT THE REPORTED COMPLAINT IS RELATED TO THE MANUFACTURING PROCESS. CORRECTIVE ACTIONS WERE IMPLEMENTED SUBSEQUENT TO MANUFACTURING OF LOT NO. 60012452 TO ADDRESS THE DEFECT. TO DATE THERE HAVE BEEN NO ADDITIONAL COMPLAINTS FROM FUTURE LOTS SINCE AFTER THE CORRECTIVE ACTIONS WERE ESTABLISHED. MOST RECENT FOLLOW-UP INFORMATION RECEIVED BY BRACCO IMAGING SCANDINAVIA/TFS FROM THE REPORTER ON 11-SEP-2019 AND SENT TO BRACCO MILAN ON THE SAME DAY, INCORPORATED ABOVE, INCLUDES: PATIENT'S DETAILS AND DATE OF INCIDENT. WITH FOLLOW-UP INFORMATION THE CASE BECAME VALID. MOST RECENT FOLLOW-UP INFORMATION RECEIVED FROM BRACCO GROUP QUALITY ON 15-NOV-2019 INCORPORATED ABOVE INCLUDES: RESULTS OF COMPLAINT HAVE BEEN PROVIDED BY BRACCO GROUP QUALITY. OUTCOME: RECOVERED. THIS CASE IS MEDICALLY CLOSED.