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

Catalog Number 062941

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

Patient Problem Peritonitis (2252)

Event Date 04/19/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On an unknown date, the patient was admitted to the hospital due to heavy stomach pain and raised temperature.It was reported that the patient's tubing was retracting back into the stomach.The patient was diagnosed with peritonitis.On (b)(6) 2022, the patient was discharged from the hospital, and prescribed unknown antibiotics for 10 days.On (b)(6) 2022, the patient went to the emergency ward due to severe stinging pain at the insertion site with pus.It was reported that the patient needed new external retention plate, and her tubing would need to be removed.It was later reported that the patient would need to be hospitalized on (b)(6) 2022 for the removal of the peg tube due to the tube "appearing to be in the way of the liver".It was reported that on (b)(6) 2022, the patient was still hospitalized.

Manufacturer Narrative

Reference record (b)(4).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.Catalog number is the international list number which is similar to us list number of 062910.Peritonitis is a known complication of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE MEDICAL DEVICE CENTRE; 1675 south lakeside drive; waukegan; 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: 14430079
• MDR Text Key: 291948561
• Report Number: 3010757606-2022-00329
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/19/2022

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: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 062941
• Device Lot Number: 32401200
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/18/2022
• Date Device Manufactured: 09/28/2020
• 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 J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female