FDA Adverse Event Other Summary report: N

MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT

MDR report key: 1445194 · Received August 19, 2009

Report

Report Number: 3006606984-2009-00001
Event Type: Other
Date Received: August 19, 2009
Date of Event: July 16, 2009
Report Date: July 16, 2009
Manufacturer: AVENT S DE RL DE CV
Product Code: KNT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INCIDENT SAMPLE WAS NOT RETURNED FOR EVALUATION. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, THE PRODUCTION RECORDS FOR THE PRODUCT CODE WAS REVIEWED FINDING NO SIMILAR OBSERVATIONS. MANUFACTURING PERFORMS 100% FUNCTIONAL/VISUAL INSPECTION OF EACH DEVICE. FOR THIS PRODUCT CODE, THIS IS THE FIRST INCIDENT REPORTED FOR THIS FAILURE MODE. WE WILL CONTINUE TO CLOSELY MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT TO IDENTIFY EMERGING TRENDS AND IF APPLICABLE, ADDITIONAL INVESTIGATIONS WILL BE INITIATED AT THE MOLDING AND PRINTING SITE AND CORRECTIVE ACTION TAKEN IF INDICATED.

Description of Event or Problem · 1

KIMBERLY CLARK RECEIVED A COMPLAINT INDICATING THAT THE INK ON THE BALLOON, JEJUNAL, AND GASTRIC VALVES WORE OFF AFTER ONE MONTH. IT WAS REPORTED THAT THE USER HAD ACCIDENTALLY FED THE PATIENT'S STOMACH FOR A FEW HOURS BEFORE SHE STOPPED THE FEEDING. THERE WAS NO REPORT OF INJURY TO THE PATIENT. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT	TRANSGASTRIC JEJUNAL TUBE	KNT	AVENT S DE RL DE CV

Patients

Seq	Age	Sex	Outcome	Treatment
1