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

Catalog Number 062943

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

Patient Problem No Code Available (3191)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event was discarded; therefore, a return sample evaluation is unable to be performed.A bezoar is a known complication of a j-tube placement.(b)(4).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 gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2020 during a tubing change, the intestinal tube had two bezoars-one in the distal area and the other in the stoma.A complete tubing replacement was performed and the tubing was discarded.

• 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: 11024928
• MDR Text Key: 222024420
• Report Number: 3010757606-2020-00804
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/20/2020

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: 06/30/2022
• Device Catalogue Number: 062943
• Device Lot Number: 32023369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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 PEG TUBE, LOT # 32023428
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR