SUPER XL ENEMA SYSTEM - 8925
Report
- Report Number
- 2411512-2020-00001
- Event Type
- Injury
- Date Received
- December 31, 2020
- Report Date
- January 26, 2021
- Manufacturer
- BRACCO DIAGNOSTICS INC.
- Product Code
- FGD
- UDI-DI
- 10815112020986
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE (B)(6) OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY (CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN (MEGLUMINE AMIDOTRIZOATE, SODIUM AMIDOTRIZOATE) (MAH, BAYER PHARMACEUTICALS) (OFF LABEL USE) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2021, THE RESULTS OF QUALITY INVESTIGATION OF THE FLEX TUBING BY THE SUPPLIER BECAME AVAILABLE. BASED ON THE PRESENT ANALYSIS, IT IS DETERMINED THAT REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS SINCE NO SAMPLES NOR PICTURES WERE AVAILABLE FOR EVALUATION AND NO DISCREPANCIES AND OR DEVIATIONS WERE DOCUMENTED THAT COULD BE RELATED TO THE REPORTED DEFECT, THEREFORE IT IS CONSIDERED THAT OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JAN-2021: THE SUPPLIER'S FLEX TUBING QUALITY INVESTIGATION REPORT WAS PROVIDED. AMENDMENT: ON (B)(6) 2021, FOLLOWING BRACCO INTERNAL REVIEW OF THIS REPORT, THE FOLLOWING EVENT WAS ADDED: OFF LABEL USE, GASTROGRAFIN USED WITH SUPER XL ENEMA SYSTEM DURING EXAMINATION OF COLON [OFF-LABEL USE OF DEVICE]. THIS CASE IS MEDICALLY CLOSED. BRACCO COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. RESULTS OF BRACCO QUALITY INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS. OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. OF NOTE, THE USE OF GASTROGRAFIN WITH THE SUPER XL ENEMA SYSTEM IS CONSIDERED OFF-LABEL USE.
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE SEPTEMBER OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIEDDIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY "(CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN"(MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ON 26-JAN-2021, THE RESULTS OF QUALITY INVESTIGATION OF THE FLEX TUBING BY THE SUPPLIER BECAME AVAILABLE. BASED ON THE PRESENT ANALYSIS, IT IS DETERMINED THAT REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS SINCE NO SAMPLES NOR PICTURES WERE AVAILABLE FOR EVALUATION AND NO DISCREPANCIES AND OR DEVIATIONS WERE DOCUMENTED THAT COULD BE RELATED TO THE REPORTED DEFECT, THEREFORE IT IS CONSIDERED THAT OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JAN-2021: THE SUPPLIER'S FLEX TUBING QUALITY INVESTIGATION REPORT WAS PROVIDED. ON 08-FEB-2021: CODING WAS ADDED TO THE REPORT, NO NEW INFORMATION WAS RECEIVED FORM THE REPORTER. THIS CASE IS MEDICALLY CLOSED. BRACCO COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. RESULTS OF BRACCO QUALITY INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS. OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. (B)(4).
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY ((B)(6) 2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE (B)(6) OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY "(CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN"(MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS CASE WAS FORWARDED TO BRACCO QUALITY ASSURANCE DEPARTMENT AND IS PENDING INVESTIGATION REPORT FINDINGS. ADDITIONAL INFORMATION IS REQUIRED. COMPANY COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. A BRACCO QUALITY INVESTIGATION IS PENDING. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. (B)(4).
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE (B)(6) OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY (CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN (MEGLUMINE AMIDOTRIZOATE, SODIUM AMIDOTRIZOATE) (MAH, BAYER PHARMACEUTICALS) (OFF LABEL USE) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED AN UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2021, THE RESULTS OF QUALITY INVESTIGATION OF THE FLEX TUBING BY THE SUPPLIER BECAME AVAILABLE. BASED ON THE PRESENT ANALYSIS, IT IS DETERMINED THAT REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS SINCE NO SAMPLES NOR PICTURES WERE AVAILABLE FOR EVALUATION AND NO DISCREPANCIES AND OR DEVIATIONS WERE DOCUMENTED THAT COULD BE RELATED TO THE REPORTED DEFECT, THEREFORE IT IS CONSIDERED THAT OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JAN-2021: THE SUPPLIER'S FLEX TUBING QUALITY INVESTIGATION REPORT WAS PROVIDED. AMENDMENT: ON (B)(6) 2021, FOLLOWING BRACCO INTERNAL REVIEW OF THIS REPORT, THE FOLLOWING EVENT WAS ADDED: OFF LABEL USE, GASTROGRAFIN USED WITH SUPER XL ENEMA SYSTEM DURING EXAMINATION OF COLON [OFF-LABEL USE OF DEVICE]. THIS CASE IS MEDICALLY CLOSED. BRACCO COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. RESULTS OF BRACCO QUALITY INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS. OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. OF NOTE, THE USE OF GASTROGRAFIN WITH THE SUPER XL ENEMA SYSTEM IS CONSIDERED OFF-LABEL USE. (B)(4).
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE SEPTEMBER OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY" (CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ON 26-JAN-2021, THE RESULTS OF QUALITY INVESTIGATION OF THE FLEX TUBING BY THE SUPPLIER BECAME AVAILABLE. BASED ON THE PRESENT ANALYSIS, IT IS DETERMINED THAT REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS SINCE NO SAMPLES NOR PICTURES WERE AVAILABLE FOR EVALUATION AND NO DISCREPANCIES AND OR DEVIATIONS WERE DOCUMENTED THAT COULD BE RELATED TO THE REPORTED DEFECT, THEREFORE IT IS CONSIDERED THAT OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JAN-2021: THE SUPPLIER'S FLEX TUBING QUALITY INVESTIGATION REPORT WAS PROVIDED. ON 08-FEB-2021: CODING WAS ADDED TO THE REPORT, NO NEW INFORMATION WAS RECEIVED FORM THE REPORTER. THIS CASE IS MEDICALLY CLOSED. BRACCO COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. RESULTS OF BRACCO QUALITY INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS. OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. (B)(4).
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY ((B)(6) 2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE (B)(6) OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY" (CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. ON 26-JAN-2021, THE RESULTS OF QUALITY INVESTIGATION OF THE FLEX TUBING BY THE SUPPLIER BECAME AVAILABLE. BASED ON THE PRESENT ANALYSIS, IT IS DETERMINED THAT REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS SINCE NO SAMPLES NOR PICTURES WERE AVAILABLE FOR EVALUATION AND NO DISCREPANCIES AND OR DEVIATIONS WERE DOCUMENTED THAT COULD BE RELATED TO THE REPORTED DEFECT, THEREFORE IT IS CONSIDERED THAT OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-JAN-2021: THE SUPPLIER'S FLEX TUBING QUALITY INVESTIGATION REPORT WAS PROVIDED. THIS CASE IS MEDICALLY CLOSED. BRACCO COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. RESULTS OF BRACCO QUALITY INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IS NOT RELATED TO FLEX MANUFACTURING PROCESS. OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. (B)(4).
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE SEPTEMBER OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY "(CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN"(MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS CASE WAS FORWARDED TO BRACCO QUALITY ASSURANCE DEPARTMENT AND IS PENDING INVESTIGATION REPORT FINDINGS. ADDITIONAL INFORMATION IS REQUIRED. COMPANY COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. A BRACCO QUALITY INVESTIGATION IS PENDING. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. (B)(4).
THIS REPORT WAS RECEIVED BY A BRACCO DISTRIBUTOR FROM A HEALTHCARE PROFESSIONAL ON 08-DEC-2020 AND WAS SENT TO BRACCO DRUG SAFETY UNIT ON THE SAME DAY (08-DEC-2020). THIS CASE WAS INITIALLY ASSESSED AS NON-REPORTABLE ON 09-DEC-2020. ON 10-DEC-2020, ADDITIONAL INFORMATION WAS PROVIDED, AND CASE WAS RE-ASSESSED AS REPORTABLE DUE TO POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. PATIENT IDENTIFIERS WERE NOT PROVIDED, THEY ARE CONFIDENTIAL DUE TO PRIVACY CONCERNS. ALL INFORMATION WAS INCORPORATED INTO THE INITIAL REPORT. THE REPORTER STATED THAT SINCE SEPTEMBER OF 2020, AN UNSPECIFIED NUMBER OF INPATIENTS AND OUTPATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATION AND COMPUTERIZED TOMOGRAPHY "(CT) SCAN(S) WITH RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. THE REPORTER ALSO STATED THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST TO PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. THE REPORTER ALSO STATED UNSPECIFIED NUMBER OF PATIENTS EXPERIENCED BLEEDING SOMETIMES FOR A COUPLE OF DAYS AND SOME OF THE PATIENTS WENT TO THE EMERGENCY ROOM. THE REPORTER HAD NO INFORMATION REGARDING TREATMENTS AND EVENT OUTCOME AS THEY DO NOT PERFORM FOLLOW-UP AFTER RELEASING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS CASE WAS FORWARDED TO BRACCO QUALITY ASSURANCE DEPARTMENT AND IS PENDING INVESTIGATION REPORT FINDINGS. ADDITIONAL INFORMATION IS REQUIRED. COMPANY COMMENT: REPORTEDLY, AN UNSPECIFIED NUMBER OF PATIENTS UNDERWENT UNSPECIFIED DIAGNOSTIC EXAMINATIONS AND CT SCANS WITH "RECTAL WATER AND SOME CASES MIXED WITH GASTROGRAFIN" (MAH, BAYER PHARMACEUTICALS) USING SUPER XL ENEMA SYSTEM. THE REPORTER STATED THE TIP OF THE SUPER XL TUBING IS VERY BIG, HARD AND IS NOT FLEXIBLE AT THE END, THEREFORE THE PATIENTS ARE EXPERIENCING PAIN/SUFFERING WHEN CONNECTING IT TO THE PATIENT'S RECTUM. REPORTEDLY, SOME PATIENTS EXPERIENCED BLEEDING WHICH SOMETIMES LASTED "A COUPLE OF DAYS" AND REQUIRED A VISIT TO THE EMERGENCY ROOM. IT WAS ALSO REPORTED THAT THE CONNECTING TUBE BETWEEN THE BAG AND THE VERY LARGE TIP ALLOWS THE WATER TO RUN FAST INTO THE PATIENT WHICH LEADS TO LEAKAGE OF THE WATER OUTSIDE OF THE BODY. TREATMENT DETAILS AND OUTCOMES WERE UNKNOWN AS THE REPORTER DOES NOT PERFORM FOLLOW-UP AFTER A PATIENT IS RELEASED. A BRACCO QUALITY INVESTIGATION IS PENDING. THIS CASE WAS ASSESSED AS REPORTABLE DUE TO THE POSSIBILITY OF SERIOUS INJURY TO PATIENTS IF THE EVENTS WERE TO RE-OCCUR. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1565964 | SUPER XL ENEMA SYSTEM - 8925 | SUPER XL ENEMA SYSTEM - 8925 | FGD | BRACCO DIAGNOSTICS INC. | 901203 | 60137723, 50593376 | 10815112020986 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | GASTROGRAFIN| GASTROGRAFIN| GASTROGRAFIN| GASTROGRAFIN| GASTROGRAFIN |