FDA Adverse Event Injury Summary report: N

KIMVENT CLOSED SUCTION SYSTEM

MDR report key: 2080495 · Received May 6, 2011

Report

Report Number: 8030647-2011-00015
Event Type: Injury
Date Received: May 6, 2011
Report Date: April 7, 2011
Manufacturer: KIMBERLY-CLARK HEALTH CARE
Product Code: BSY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE REVIEW OF THE DEVICE HISTORY RECORD IS NOT COMPLETED AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SAMPLE WAS RETURNED TO KIMBERLY-CLARK FOR EVALUATION. THE 4.0 'Y' ADAPTER WAS RETURNED,AND THE TIP OF THE ADAPTER WAS MISSING. VISUAL EVALUATION UNDER MAGNIFICATION INDICATED THAT THE TIP OF THE ADAPTER BROKE AWAY FROM THE DEVICE. THE ROOT CAUSE FOR BREAKAGE OF THIS POLYMER MOLDED COMPONENT COULD NOT BE DETERMINED. 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.

Description of Event or Problem · 1

KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(6), STATING, "A PIECE OF THE CONNECTOR BROKE OFF AND FELL IN THE TUBE CAUSING AIRFLOW OBSTRUCTION AND EMERGENCY RE-INTUBATION." 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. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	KIMVENT CLOSED SUCTION SYSTEM	CLOSED SUCTION	BSY	KIMBERLY-CLARK HEALTH CARE		M8322T703

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention