FDA Adverse Event Malfunction Summary report: N

ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

MDR report key: 3952949 · Received May 20, 2014

Report

Report Number: 9611710-2014-00123
Event Type: Malfunction
Date Received: May 20, 2014
Date of Event: June 9, 2011
Report Date: July 18, 2011
Manufacturer: UNOMEDICAL SDN BHD
Product Code: BTR
PMA / PMN Number: K96238
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ONE (1) UNUSED SAMPLES RECEIVED ON 07/11/2011 AND TESTED ON 08/01/2011 RESULTS FROM THE INVESTIGATION ARE AS FOLLOWS: PRODUCT WAS REMOVED FROM THE UNIT PACK AND THOROUGHLY EXAMINED. FLOATING PARTICLE WAS FOUND INSIDE THE PACKAGE AND CONSIDERED "NOT ACCEPTABLE" AS PER INSPECTION CRITERIA. REVIEW OF ASSEMBLY RECORDS SHOWED NO SIGNS OF ASSOCIATED DEFECTS DETECTED DURING THE 100% LIGHT TEST. BASED ON THE FINDINGS, IT IS CONCLUDED THAT THE COMPLAINT WAS CONFIRMED AS PER RETURNED SAMPLES. AN INTERNAL COMPLAINT, AND THIS PARTICULAR LOT (608052R001) IDENTIFIED WAS CONFIRMED TO BE MANUFACTURED BEFORE IMPLEMENTATION OF THE CAPA. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY CONVATEC FOR COMPLAINTS RECEIVED FROM MAY 1, 2011 - SEPTEMBER 30, 2013. CONVATEC WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO CONVATEC INC'S COMPLAINT HANDLING AND CAPA PROCEDURES.

Description of Event or Problem · 1

DETAILS OF THE COMPLAINT: "QTY : 1 FOREIGN SUBSTANCE: SUBSTANCE LIKE LINT OR SOMETHING."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298938	ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT	TUBE, TRACHEAL (W/WO CONNECTOR)	BTR	UNOMEDICAL SDN BHD	61214070	608052R001

Patients

Seq	Age	Sex	Outcome	Treatment
1