MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA

Catalog Number DUODOPA INTESTINAL TUBE

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

Patient Problems Bowel Perforation (2668); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2021

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.It was unknown if the device involved in the event was discarded or will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.A bezoar, pneumoperitoneum, and gastric intestinal perforation are known complications 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 jejunal tube (j-tube).On (b)(6) 2021, the patient began duodopa therapy.On (b)(6) 2021, the patient was admitted to the emergency unit due to severe abdominal pain and vomiting and nausea.A ct of the abdomen revealed that the j tube was in the intestine and there was edema / fluid ventral at the colon descendent and a little fluid at pelvis minor with a mention of subileus obs.It was reported that the patient had a bezoar and duodopa therapy was held.On (b)(6) 2022, the patient again experienced severe pain in the abdomen and a ct scan revealed considerable free air and fluid inside the abdomen.During surgery, the gastric surgeon found that the inner tube had perforated the intestinal wall and the patient underwent repair for the intestinal perforation.The neurologist, gastroenterologist, and the surgeon believed that the intestinal perforation was caused by the end of the inner tube (j-tube).The patient underwent placement of a normal percutaneous endoscopic gastrostomy (peg) tube for feeding and opted not to place an inner tube for fear of the potential of this happening again.

• Brand Name: DUODOPA_DUOPA
• 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: 13389467
• MDR Text Key: 285670649
• Report Number: 3010757606-2022-00053
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IC
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DUODOPA INTESTINAL TUBE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2021
• 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: UNKNOWN PEG TUBE MANUFACTURER
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female