FDA Adverse Event Malfunction Summary report: N

FLEXI-SEAL CONTROL FMS KIT US

MDR report key: 3843686 · Received March 25, 2014

Report

Report Number: 2243969-2014-00134
Event Type: Malfunction
Date Received: March 25, 2014
Date of Event: February 5, 2014
Report Date: February 28, 2014
Manufacturer: CONVATEC INC.
Product Code: KNT
PMA / PMN Number: K112342
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. COMPLAINANT CONFIRMS NO LOT INFORMATION AVAILABLE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC MANUFACTURING SITE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. 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

IT IS REPORTED THAT COMPLAINANT EXPERIENCED DEFLATION DIFFICULTIES BASED ON THE BULB LOSING AIR AFTER INFLATED INTO THE RECTUM (ON PATIENTS WITH APPROPRIATE RECTAL TONE). WHEN THE BULB LOSES AIR, THE TUBING SLIDES OUT OF THE PATIENT'S RECTAL VAULT, THUS RENDERING THE PRODUCT USELESS ACCORDING TO NURSE. IN ADDITION, COMPLAINANT WAS UNABLE TO DEFLATE THE FMS BALLOON RESULTING IN CUTTING THE TUBING TO RELEASE THE WATER. A NEW FMS WAS INSERTED RESULTING IN NO HARM TO PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
174156	FLEXI-SEAL CONTROL FMS KIT US	GASTROINTESTINAL TUBE AND ACCESSORIES	KNT	CONVATEC INC.	411107	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1