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

Catalog Number 062941

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

Patient Problems Sepsis (2067); Peritonitis (2252); Bowel Perforation (2668)

Event Date 06/05/2022

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was removed and was not returned; therefore, a return sample evaluation is unable to be performed.Catalog number in is the international list number which is similar to us list number of 062910.Peritonitis, sepsis and intestinal perforation are known complications of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021, 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) 2022, the patient was hospitalized due to hypotension, dehydration, abdominal pain, and loss of consciousness.On (b)(6) 2022, the patient had yellow stoma site discharge, and was diagnosed with an unknown infection.On (b)(6) 2022, the patient was diagnosed with sepsis due to peritonitis secondary to bowel perforation, location was unknown.The patient underwent surgery in which an unknown portion of the intestine was removed and was treated with unknown iv antibiotics.The patient's peg and j tube were removed, and duodopa therapy was suspended.It was unknown if the intestinal perforation was due to the peg tube or the j tube.On (b)(6) 2022, the patient passed away due to complications from peritonitis.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE MEDICAL DEVICE CENTRE; 1675 south lakeside drive; waukegan; 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: 15108582
• MDR Text Key: 296658224
• Report Number: 3010757606-2022-00488
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 062941
• Device Lot Number: 32235109
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/26/2022
• Date Device Manufactured: 06/07/2019
• 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: ABBVIE J-TUBE, LOT # 32341119
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female