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

Catalog Number 062910-001

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 discarded and not returned; therefore, a return sample evaluation is unable to be performed.Buried bumper is 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) 2013, 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) 2018, the patient was diagnosed with a buried bumper during endoscopy.The peg-j tube was surgically removed and replaced with new peg-j tubing.

• Brand Name: ABBVIE PEG
• 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: 8213790
• MDR Text Key: 131966690
• Report Number: 3010757606-2019-00004
• 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: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 062910-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• 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: J-TUBE - UNKNOWN MANUFACTURER
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR