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

Catalog Number 062918-001

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

Patient Problems Death (1802); Obstruction/Occlusion (2422); Bowel Perforation (2668)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

Reference number (b)(4).The device involved in the event was not returned; therefore, a return sample evaluation is unable to be performed.Small bowel obstruction, perforation and knotted tube are known complications of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

In (b)(6) 2017, a patient underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, the patient's daughter reported that the patient had been hospitalized for intermittent abdominal cramping, nausea and vomiting, which had occurred for a few weeks.On (b)(6) 2019, laparoscopic exploratory surgery was performed for a partial bowel obstruction.The physician reported that an x-ray showed a knot in the j tube caused the obstruction and the tubing was removed.On (b)(6) 2019, the patient's blood pressure dropped and the patient was transferred to icu.The patient continued to decline and was taken back to surgery.It was discovered that the bowel had completely perforated.A surgical repair was done and intravenous antibiotics were administered.On (b)(6) 2019, the patient expired at the hospital.An autopsy was not performed.

• Brand Name: ABBVIE J
• 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: 8294019
• MDR Text Key: 134636081
• Report Number: 3010757606-2019-00075
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/11/2019

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: 062918-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PEG TUBE, UNKNOWN MANUFACTURER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR