MAUDE Adverse Event Report: ABBVIE - MEDICAL DEVICE CENTER ABBVIE PEG; KNT - GASTROINTESTINAL TUBE AND ACCESSORIES

Catalog Number 062910-001

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Catalog number 062941-001 is the international list number which meets the requirements of the similar product listed which is the us list number.The device involved in the event was not returned, it remains implanted; therefore a return sample evaluation is unable to be performed.Peritonitis is a known complication of a peg tube placement.The instructions for use indicate to secure the peg tube, pull on the abbvie peg tube until elastic resistance is felt and keep under tension and abbvie peg tube should remain under moderate tension for 24-72 hours to promote good adherence to the stomach wall to the inner abdominal wall.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.

Event Description

On (b)(6) 2017, patient in (b)(6) underwent placement of percutaneous endoscopic gastrostomy (peg) tube.The patient experienced excessive abdominal pain and leakage of gastric fluid at the stoma site.During the weekend, patient developed peritonitis and required a laparotomy and washout on (b)(6) 2017.Patient was treated in the intensive care unit (icu) for 3 days and was given total parenteral nutrition.The patient was diagnosed with clostridium difficile in stool.Patient received antibiotics gentamicin, metronidazole and ampicillin.Report stated that the laparotomy findings indicated that the peg tube was not properly secured within the fixation plate, thus leading to peritonitis as the peg tube was sitting quite loosely into the stomach.It was unknown how long it was not properly secured for, or how it became unsecured, it is likely that the patient has played with the tubing.There were two sutures securing the peg in place externally for one week.The duodopa was temporarily suspended and the titration was resumed on (b)(6) 2017.

• Brand Name: ABBVIE PEG
• Type of Device: KNT - GASTROINTESTINAL TUBE 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
• MDR Report Key: 6722994
• MDR Text Key: 80382586
• Report Number: 3010757606-2017-00319
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2017

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: 11/30/2018
• Device Catalogue Number: 062910-001
• Device Lot Number: 32265205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR