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 Problems Sepsis (2067); Peritonitis (2252); Post Operative Wound Infection (2446)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Reference record (b)(4).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.The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection and peritonitis are a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube, external triangle bumper secured to the patient with 3 stitches.On (b)(6) 2019, the patient experienced hypotension with two episodes of syncope, which extended post-operative hospitalization.In (b)(6) 2019 the patient experienced a stoma site infection with purulent fluid discharge and serous fluid discharge from surgical site.On (b)(6) 2019, the patient experienced abdominal pain; blood tests and scan was performed which resulted in sepsis and free liquid in abdominal cavity.The patient was treated with intravenous antibiotics, tazocel for seven days.On (b)(6) 2019 the neurologist removed post-surgical drains.On (b)(6) 2019 it was reported that the patient's sepsis and peritonitis resolved and the patient was discharged from the hospital on (b)(6) 2019.

Manufacturer Narrative

Reference record (b)(4).

Event Description

Corrected data added.

• Brand Name: DUODOPA_DUOPA
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): ABBVIE - MEDICAL DEVICE CENTER; 1675 lakeside drive; waukegan IL 60085
• MDR Report Key: 9521835
• MDR Text Key: 184507231
• Report Number: 3010757606-2019-00935
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K142793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 062941
• Device Lot Number: 32312218
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN J-TUBE, LOT # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 43