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

Catalog Number 062910

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

Patient Problems Abscess (1690); Sepsis (2067); Aspiration Pneumonitis (4455)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).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.Catalog number is the similar us list number, the international list number is unknown.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.Aspiration pneumonia, abscess, and sepsis are known complications of a peg tube/ j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

The complaint was received from netherlands and dates for any of the events were not specified.Patient underwent procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube, the patient experienced septic shock; being alleged by reporter as ¿¿ "in liver abscess possibly caused by a bacteria after placement of pegj".Ileus and aspiration pneumonia was also reported and patient was placed on a ventilator.Several query attempts have been made regarding causality , alleged device related adverse event, malfunctions , complications and event dates but no additional information was provided.Therefore, abbvie has conservatively chosen to report these events.

• 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: 16336759
• MDR Text Key: 309168436
• Report Number: 3010757606-2023-00097
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• 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: Prefer Not To Disclose