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

Catalog Number DUODOPA PEG TUBE

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

Patient Problem No Code Available (3191)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.A pneumoperitoneum is a known complication of a peg tube placement.A pneumoperitoneum is a known complication of a peg tube/ j-tube placement.Per the instructions for use (ifu): to secure the peg tube, the peg tube should be pulled until elastic resistance is felt, keep under tension, secure fixation plate 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.(b)(4).If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, a patient in poland underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, the patient experienced severe abdominal pain / tender abdomen in the mesogastrium with no peritoneal symptoms with peristalsis present and was hospitalized on (b)(6) 2019.On (b)(6) 2019, an abdominal x-ray revealed gas under the diaphragm domes.During gastroenterological consultation on (b)(6) 2019, piperacillin and tazobactam were recommended and a zero diet.On (b)(6) 2019, the patient had increased inflammatory parameters of crp and wbc were observed.On (b)(6) 2019, a gastroenterological consultation catheter sealing was corrected and continuation of symptomatic treatment was recommended.In the following days, the patient's condition gradually improved, abdominal discomfort subsided, and the inflammatory parameters decreased.On (b)(6) 2019, the patient was discharged home.

• 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: 11158217
• MDR Text Key: 226660616
• Report Number: 3010757606-2021-00029
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/17/2020

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 Catalogue Number: DUODOPA PEG TUBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/13/2021
• 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: UNKNOWN J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 40