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

Catalog Number 062943

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/01/2024

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient in greece underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2024, in an unscheduled nursing visit, the patient reported she felt the intestinal tube was being pulled in, which was not found at the visit.A gastroscopy was performed, and it was found that a loop of the intestinal tube had formed at the location of the bulb, which according to the gastroenterologist caused the feeling of pain that the patient had mentioned.In addition, a bezoar was found at the end of the intestinal tube.The old tubes were removed and were available for return.An endoscopically assisted percutaneous gastroenterostomy was placed.In the 2nd part of the duodenum, on the ampulla of vater, hyperextended and reddened mucosa and mild bleeding from this point were found.The patient was prescribed losec tablets twice a day for 7 days.

Manufacturer Narrative

Reference number (b)(4).The j tube was received by abbvie for examination.A visual inspection was performed.A dried bezoar was observed around the j-tube bolus.Bezoar is verified since a bezoar was observed.Catalog number in d4 is the international list number which is similar to us list number of 062918.H6 code of 4581 was chosen to capture the event of bezoar.Bezoar is a known complication of a peg- j tube placement.H6 code of 4581 was chosen to capture the event of bezoar.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

• 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: 18990399
• MDR Text Key: 338783629
• Report Number: 3010757606-2024-000018
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2024
• Device Catalogue Number: 062943
• Device Lot Number: 32491240
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PEG TUBE, LOT # UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female