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

Catalog Number 062910

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

Patient Problems Aspiration/Inhalation (1725); Death (1802); Pneumonia (2011)

Event Date 01/01/2021

Event Type  Death  

Manufacturer Narrative

Reference record (b)(4).The device manufacturer and lot number of the peg tube involved in this event was not provided by the complainant.Therefore, it is unknown if the tubing involved was the abbvie peg tube.Abbvie has chosen to report this event due to the potential that the peg tube involved could have been the abbvie peg tube.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021, patient underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.Wife reported that the peg j tube surgery went fine, but patient aspirated on intestinal fluid and was hospitalized.It was reported that the patient developed pneumonia and was extremely weak.Wife is unsure if peg j tube insertion is related to the aspiration pneumonia.The patient was admitted to step-down intensive care unit with a diagnosis of possible aspiration pneumonia.The patient was treated with unknown intravenous antibiotics.Additional information received indicates the nurse care manager reported that the patient was admitted after the peg-j placement due to aspiration and was placed on ventilator.Patient passed away on wednesday (b)(6) 2021.

• 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: 11281195
• MDR Text Key: 230349026
• Report Number: 3010757606-2021-00063
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/27/2021

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: 062910
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/04/2021
• 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: J TUBE- MANUFACTURER UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR