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

Catalog Number 062903

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

Patient Problem Aspiration Pneumonitis (4455)

Event Date 06/20/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient in greece underwent a procedure for the placement of nasal jejunal tube.After insertion, the patient developed a mild cough.During lunch, the nurse noticed that the wife was feeding the patient in a supine position and despite the recommendations not to feed him in this position, she continued to do so.After the visit by the treating physician, a recommendation was made for examination by a pulmonologist due to auscultation and intense cough.The pulmonologist's assessment was that the patient developed acute pneumonia.The patient was discharged to the hospital of the city where he resides, to treat the pneumonia.The patient removed the nasal jejunal on his own after the visit of the treating physician due to the fact that he was quite stimulated.

Manufacturer Narrative

Reference number (b)(4).Catalog number is the international list number which is similar to us list number of 062903.The device involved in the event was discarded and was not returned; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia is a known complication of an nj 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: 14982883
• MDR Text Key: 295678684
• Report Number: 3010757606-2022-00453
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K142792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/11/2022

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 Expiration Date: 04/14/2024
• Device Catalogue Number: 062903
• Device Lot Number: 1149793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 85 KG