MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number 062941

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001); Sepsis (2067); Peritonitis (2252)

Event Date 02/03/2020

Event Type  Death  

Manufacturer Narrative

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; the disposition of the device was unknown.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.

Event Description

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.After the procedure, the patient remained hospitalized for severe pain.On (b)(6) 2020, a ct scan was taken, which showed a lot of air and fluid in the lungs.The surgeon then tightened the peg tube, as it was determined to be too loose.On an unknown date, it was discovered that the patient had fluid in the abdominal cavity.It was also discovered that the stomach had been perforated, which caused fluid to leak into the abdominal cavity.On (b)(6) 2020, the patient underwent urgent surgery.While cleaning out the abdominal cavity, it was discovered the patient had peritonitis and abdominal sepsis.It was decided there was nothing more they could do, so the surgeon closed the abdominal cavity, and the patient was given pain relief.The patient passed away on (b)(6) 2020.The cause of death was reported as unknown.It was unknown if an autopsy was performed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer (Section G): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• Manufacturer Contact: terry ingram ; 1675 lakeside drive; waukegan, IL 60085 ; 8479385350
• MDR Report Key: 9769872
• MDR Text Key: 181379231
• Report Number: 3010757606-2020-00150
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 062941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: J-TUBE - UNKNOWN MANUFACTURER AND LOT #
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 35