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

Catalog Number DUODOPA PEG TUBE

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

Patient Problems Anemia (1706); Ulcer (2274)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Reference record (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.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.Gastrointestinal ulcers are 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 an unknown date, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2021, the patient experienced muscle tone loss, tremors, freezing, and weakness.On an unknown date, the patient experienced vomiting blood.The neurologist suspected the j-tube was not in the correct position.On (b)(6) 2021, the patient underwent an endoscopy to re-position the j-tube.During the endoscopy, am inactive gi bleed from esophageal and stomach ulcers was discovered.The j-tube was re-positioned during the endoscopy.The hemoglobin of the patient was 7.5.On (b)(6) 2021, the patient was hospitalized and received a unit of blood.The patient was also treated with pepcid and iron.On (b)(6) 2021, the patient had subsequent hemoglobin levels of 8.2 and 8.3.The patient was discharged from the hospital on (b)(6) 2021.

Manufacturer Narrative

Reference record (b)(4).

Event Description

On 14-jan-2021, information was received confirming that the patient had non-abbvie tubing at the time of the ulcers and anemia.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 11259088
• MDR Text Key: 229653730
• Report Number: 3010757606-2021-00073
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DUODOPA PEG TUBE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: J-TUBE - UNKNOWN MANUFACTURER AND LOT #; J-TUBE - UNKNOWN MANUFACTURER AND LOT #
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 72