UMBILICAL CATHETER
Received Oct 10, 2018 · Event occurred Dec 11, 2017
Report 2245270-2018-00069 · MDR key 7953303
Device
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
Not reported
- Liver Contusion
- Foreign Body In Patient
- Liver Contusion
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
MDR REPORT 2245270-2018-00069 REPLACES 2245270-2019-00069. THE INVOLVED SAMPLE IS NOT AVAILABLE AND WE DON'T RECEIVE ANY ADDITIONNAL INFORMATION FROM THE USER. THERE IS NO FURTHER INVESTIGATION OR INFORMATION ABOUT THIS EVENT. WE HAVE CHECKED THE HISTORY OF COMPLAINTS, NO FURTHER COMPLAINTS ARE REGISTERED ON THIS BATCH. THE BATCH REVIEW DOES NOT SHOWN ANY DEVIATION OR NON-CONFORMITY.
Description of Event or Problem
THE UMBILICAL CATHETER WAS INSERTED ON THE (B)(6) 2017 FOR PARENTERAL NUTRITION . THE (B)(6) A HEPATOMEGALY WAS DISCOVERED BY XR. THIS CATHETER WAS 8 DAYS IN PLACE. ON (B)(6) BY XR CONFIRMED BY ABDOMINAL ULTRASOUND , INTRAHEPATIC LIQUID WAS NOTICED , APPROXIMATELY 60CM3. ON (B)(6) WITH EPICUTANEOCATHETER NTP PASSING. PATIENT STABLE EVOLUTION. ON (B)(6) ULTRASOUND CONTROL SHOWS DECREASE OF INTRAHEPATIC COLLECTION ON (B)(6) PATIENT WEIGHT 1868, ABDOMINAL COLLECTION HAS DECREASED BY 75%, WAS ALLOWED TO GO HOME WITH AMBULATORY "KANGAROO". WE HAVE NO INFORMATION RELATED TO THE UMBILICAL CATHETER REMOVAL. FURTHERMORE, THE LINK BETWEEN THE HEPATOMEGALY AND THE UMBILICAL CATHETER IS NOT CLEARLY ESTABLISHED.
Additional Manufacturer Narrative
WE ARE WAITING FOR THE INVOLVED SAMPLE FOR INVESTIGATION. WE HAVE CHECKED THE HISTORY OF COMPLAINTS, NO FURTHER COMPLAINTS ARE REGISTERED ON THIS BATCH. THE BATCH REVIEW DOES NOT SHOWN ANY DEVIATION OR NON-CONFORMITY.
Description of Event or Problem
THE UMBILICAL CATHETER WAS INSERTED ON THE (B)(6) 2017 FOR PARENTERAL NUTRITION. THE (B)(6) A HEPATOMEGALY WAS DISCOVERED BY XR. THIS CATHETER WAS 8 DAYS IN PLACE. ON (B)(6) BY XR CONFIRMED BY ABDOMINAL ULTRASOUND , INTRAHEPATIC LIQUID WAS NOTICED, APPROXIMATELY 60CM3. ON (B)(6) WITH EPICUTANEOUS CATHETER NTP PASSING. PATIENT STABLE EVOLUTION. ON (B)(6) ULTRASOUND CONTROL SHOWS DECREASE OF INTRAHEPATIC COLLECTION. ON (B)(6) PATIENT WEIGHT (B)(6), ABDOMINAL COLLECTION HAS DECREASED BY 75%, WAS ALLOWED TO GO HOME WITH AMBULATORY "KANGAROO". WE HAVE NO INFORMATION RELATED TO THE UMBILICAL CATHETER REMOVAL. FURTHERMORE, THE LINK BETWEEN THE HEPATOMEGALY AND THE UMBILICAL CATHETER IS NOT CLEARLY ESTABLISHED.