FDA Adverse Event Malfunction Summary report: N

KIMVENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS

MDR report key: 1982902 · Received February 9, 2011

Report

Report Number: 1033422-2011-00006
Event Type: Malfunction
Date Received: February 9, 2011
Manufacturer: KIMBERLY-CLARK HEALTH CARE
Product Code: BTR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

WE WERE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE FROM THE INCIDENT WAS NOT RETURNED FOR EVALUATION. SAMPLES FROM PREVIOUS SIMILAR COMPLAINTS BY THE SAME USER FACILITY SHOWED EVIDENCE OF EXCESSIVE BITING AND CHEWING. DIRECTIONS FOR USE CAUTION, "A BITE BLOCK SHOULD BE USED IN CASES WHERE THE PATIENT MAY BITE DOWN AND FLATTEN THE ENDOTRACHEAL TUBE." 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 TO KIMBERLY-CLARK BY THE CUSTOMER.

Description of Event or Problem · 1

KIMBERLY-CLARK RECEIVED A REPORT STATING, "INCIDENT HAS OCCURRED WHERE THE PATIENT BIT THROUGH THE PILOT LINE AND HAD TO BE EXTUBATED AND RE-INTUBATED. THE PATIENT IS OKAY." 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 RECORD (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KIMVENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS	MICRO CUFF ET TUBE	BTR	KIMBERLY-CLARK HEALTH CARE		NOT PROVIDED

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention