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

Catalog Number 062918

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

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

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.Catalog number is the us list number.The international list number is unknown.The device involved in the event remained implanted in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Aspiration pneumonia is a known complication of a j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.Patient has had lcig since (b)(6) 2012.The patient received a new j-tube between (b)(6) 2019.On (b)(6) 2019 it was reported the patient was intubated and ventilated in the icu, has a pronounced candiemia which is treated with multiple intravenous antimyoticas.It was reported (b)(6) 2019 there was questionable wrong position of the j-tube.X-ray images cannot be assessed as they were done without contrast medium.Pump is running via peg in case the j-tube was positioned too deep.Patient remains intubated and ventilated.Patient to receive a tracheotomy on (b)(6) 2019 to enable patient to be weaned off of the ventilator.Per the treating physician, the patient has the following illnesses: massive mycosis since more than 30 days (detectable in blood), cause seems to be an artificial heart valve and a pacemaker that was implemented on an unknown date.Thrombocyte anemia with substitution by thrombocyte concentrate, aspiration pneumonia that occurred in the intensive care unit (date of diagnosis and treatment unknown), bladder carcinoma, tumor detection in bone marrow, and liver metastasis.

• 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: 9176517
• MDR Text Key: 162603332
• Report Number: 3010757606-2019-00699
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K142816
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2019
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR