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

Catalog Number DUODOPA INTESTINAL TUBE

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  

Manufacturer Narrative

Reference number (b)(4).Catalog number in d4 is the similar us list number, the international list number is unknown.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.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 was discarded; therefore, a return sample evaluation is unable to be performed.H6 code of 4581 was chosen to capture the event of bezoar.Bezoar is a known complication of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2024, the patient experienced a suspected bezoar.The tubing was removed and the bezoar was confirmed.

• 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: 18978973
• MDR Text Key: 338606864
• Report Number: 3010757606-2024-000017
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DUODOPA INTESTINAL TUBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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, UNKNOWN LOT#
• Patient Outcome(s): Required Intervention