FDA Adverse Event Injury Summary report: N

GASTROSTOMY FEEDING TUBE

MDR report key: 1905682 · Received November 23, 2010

Report

Report Number: 9611594-2010-00093
Event Type: Injury
Date Received: November 23, 2010
Manufacturer: KIMBERLY-CLARK HEALTH CARE
Product Code: KNT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT COMPLETED. A SAMPLE WAS NOT RETURNED TO (B)(6) FOR EVALUATION. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED BY THE CUSTOMER TO (B)(6).

Description of Event or Problem · 1

(B)(6) RECEIVED A REPORT FROM (B)(6) STATING, " TUBE INSERTED (B)(6) 2010 LOT # AA0039D07. FEEDING COMMENCED IN WARD, BUT WHEN SUCTIONING HIS TRACHEOSTOMY TUBE, HIS NURSE FOUND THAT THE ASPIRATE WAS FEED. THIS HAPPENED SEVERAL TIME OVER THE COURSE OF THE NEXT FEW DAYS AND THE PATIENT WAS UNWELL BECAUSE OF THIS ASPIRATION. ON (B)(6) 2010 PATIENT WAS RECEIVING FEED THROUGH THIS TUBE. HIS NURSE CHECKED ON HIS FEED @ 0430HRS- NO PROBLEMS IDENTIFIED. AT 1015HRS HIS NURSE FOUND THE TUBE HAD FALLEN OUT OF THE PATIENT AND THE BALLOON DEFLATED." (B)(6) 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 (B)(6) COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GASTROSTOMY FEEDING TUBE	G TUBE	KNT	KIMBERLY-CLARK HEALTH CARE		AA0039D07

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other