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 Problems Sepsis (2067); Aspiration Pneumonitis (4455)

Event Date 02/01/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a patient in germany underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.In (b)(6) 2019, the patient experienced sepsis after aspiration pneumonia.Abbvie has made multiple querying attempts, however, no further information was provided regarding the onset date of the aspiration pneumonia and sepsis, if it occurred before or after the tubing was implanted, what diagnostic tests were performed or treatment provided.Abbvie has chosen to conservatively report this event.

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 remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia and sepsis are known complications of a peg- j tube placement.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: 18016863
• MDR Text Key: 326676068
• Report Number: 3010757606-2023-00727
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/05/2023
• 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: J TUBE, UNKNOWN MANUFACTURER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female