REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062910. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. PERITONITIS IS A KNOWN COMPLICATION OF A PEG TUBE/ J-TUBE PLACEMENT. PER INSTRUCTIONS FOR USE (IFU), THE PEG TUBE SHOULD BE PULLED UNTIL ELASTIC RESISTANCE IS FELT, KEPT UNDER TENSION, FIXATION PLATE SHOULD BE SECURED INTO POSITION USING THE CLIP, AND REMAIN UNDER MODERATE TENSION FOR 24-72 HOURS TO PROMOTE GOOD ADHERENCE TO THE STOMACH WALL TO THE INNER ABDOMINAL WALL. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
D
Patient 1
ON (B)(6) 2020, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. ON (B)(6) 2020, THE PATIENT EXPERIENCED ABDOMINAL PAIN. A C-REACTIVE PROTEIN (CRP) LEVEL WAS DRAWN ON (B)(6) 2020, WITH AN ELEVATED RESULT OF 195. AN ABDOMINAL CT WAS ALSO PERFORMED, WITH NO FINDINGS. ON (B)(6) 2020, THE PHYSICIAN SUSPECTED PERITONITIS, AND THE PATIENT WAS TREATED WITH THE IV ANTIBIOTICS ZINACEF 1.5 G AND METRONIDAZOLE 500 MG WHILE HOSPITALIZED. THE PATIENT WAS ALSO TREATED WITH TRAMAL AND PANADOL FOR PAIN. ON (B)(6) 2020, THE PATIENT DIED, AND THE CAUSE OF DEATH WAS SUSPECTED AS SEPSIS. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. THE PEG-J TUBING HAD NOT BEEN REMOVED PRIOR TO THE DEATH.