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

Catalog Number 062943

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

Patient Problems Bowel Perforation (2668); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/30/2022

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).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.Catalog # is the international list number which is similar to us list number of (b)(4).Code (b)(4).Pneumoperitoneum and gastro 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)2022 , a patient in australia underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6)2022 , the patient experienced abdominal discomfort and underwent a ct scan.It was stated in the ct scan that a prior discharge summary described that the patient experienced "complications by pneumoperitoneum" following pej placement.The ct scan stated that at the time of the scan "there was no pneumoperitoneum".The ct scan also revealed that the patient's j tube "passes out of the lumen of the duodenum inferiorly for a short distance of about 12mm.It lies within the extra-duodenal fat tissue before re-entering the duodenum and then passing normally within the lumen of the fourth part of the duodenum and jejunum.The tip of the tube within the jejunum is intraluminal.There is no evidence of leaked fluid focal fluid collection or abscess at the point where the tube lies outside the duodenum¿.The patient's discharge summary was not provided, and after multiple query attempts, no further information was available.

• 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: 16296593
• MDR Text Key: 308783871
• Report Number: 3010757606-2023-00084
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142816
• 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: 02/02/2023

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: 062943
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/03/2023
• 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 PEG TUBE, LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Prefer Not To Disclose