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 Problems Aspiration/Inhalation (1725); Pneumonia (2011)

Event Date 09/21/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia is a known complication of a nj tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2021, a patient in (b)(6) underwent a procedure for the placement of naso jejunal (nj) tube.On (b)(6) 2021 it was reported the patient presented with spo2: 75% overnight.An oxygen mask was placed and resulted in improvement (spo2: 93%).Suspected aspiration pneumonia was identified.Peg/j placement procedure scheduled for (b)(6) 2021.In the afternoon of (b)(6) 2021 the patient holds a 40% 10lt venturi oxygen mask and presents 95% improved spo2 saturation.The patient receives antibiotic dalacin 600mg (1x2) iv for the suspected aspiration pneumonia.The scheduled peg/j placement procedure was canceled because a feeding tube will initially be placed.The peg / j placement procedure will take place in two months.The nj tube was removed, the levin tube remains.The patient is waiting in the hospital for the placement of the feeding tube.The patient's clinical condition is steady with venturi oxygen mask 40% 10lt and spo2 saturation 95%.It was clarified that the swallowing problems (medical history) worsened due to the possible aspiration pneumonia and for this reason a gastrostomy will be performed to place a feeding tube.

• 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: 12643828
• MDR Text Key: 278614104
• Report Number: 3010757606-2021-00705
• 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: foreign,health professional,o
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/16/2021

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: Health Professional
• Device Expiration Date: 01/29/2022
• Device Catalogue Number: 062903
• Device Lot Number: 1110139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 85