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

Catalog Number 062910

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

Patient Problem Bowel Perforation (2668)

Event Date 06/17/2023

Event Type  Injury  

Manufacturer Narrative

Reference number (b)(4).The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Intestinal perforation is a known complication of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2023, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.The patient was discharged home the same day.On (b)(6) 2023, the patient went to the emergency room due to pain.The emergency room reported there was no drainage or bleeding observed.On (b)(6) 2023, the patient was transferred from an outside hospital for a perforated bowel and abdominal pain.The doctor's note stated that the external bumper was removed by the trauma surgeon during an exploratory laparotomy.The patient did not have a tube replacement, and it was not reported that the peg or j tube was removed.On (b)(6) 2023, the patient was discharged with the bowel perforation and abdominal pain resolved.On (b)(6) 2023, the patient was titrated and medication was started with morning dose and continuous dose running.There was no malfunction or deficiency of the device reported.Due to the timing of the intestinal perforation after the peg/j tube insertion, abbvie has chosen to conservatively report this event.

• 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: 17455171
• MDR Text Key: 320376280
• Report Number: 3010757606-2023-00540
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 062910
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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: ABBVIE J TUBE, UNKNOWN LOT #
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female