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

Catalog Number 062941

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 a patient in switzerland underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube and percutaneous endoscopic jejunal tube (j-tube).On (b)(6) 2023 the patient experienced abdominal pain and was treated with unspecified analgesics.On 15 nov 2023 the patient fell down and the j tube came out.Due to the reinsertion of the j tube to check for placement and abdominal pain, a computed tomography (ct) was ordered which revealed air in the abdomen.It was reported that the patient was at risk for peritonitis and was prescribed unspecified intravenous antibiotics for five days.At the time of report, the abdominal pain was resolving.

Manufacturer Narrative

Reference record 2349981 catalog number in d4 is the international list number which is similar to us list number of 062910.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.A pneumoperitoneum is a known complication of a peg tube/ j-tube placement.Health effect clinical code of 4581 was chosen to capture the event of pneumoperitoneum.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 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: 18326400
• MDR Text Key: 330497332
• Report Number: 3010757606-2023-00846
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/14/2023

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 Catalogue Number: 062941
• Device Lot Number: 32371391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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, LOT # 32411340
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male