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

Catalog Number 062945

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

Patient Problems Pneumonia (2011); Sepsis (2067)

Event Date 01/24/2022

Event Type  Death  

Event Description

On (b)(6) 2022, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date in (b)(6) 2022, the patient was admitted to the intensive care unit at the hospital due to sepsis.On (b)(6) 2022, the patient developed multi-organ failure and died.The caregiver reported that the patient had recurrent pneumonia, which is what led to the sepsis.The date of onset of the pneumonia was unknown and if it occurred before the placement of the peg-j tubing.

Manufacturer Narrative

(b)(4).Catalog number is the international list number which is similar to us list number of 062912.The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.Post-procedural complications of pneumonia and sepsis are known complications of a peg 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: 13535978
• MDR Text Key: 285631066
• Report Number: 3010757606-2022-00085
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/15/2022

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: Health Professional
• Device Catalogue Number: 062945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/15/2022
• 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: ABBVIE J-TUBE - UNKNOWN LOT #.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male