FDA Adverse Event Malfunction Summary report: N

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

MDR report key: 4121456 · Received July 29, 2014

Report

Report Number: 1049092-2014-00352
Event Type: Malfunction
Date Received: July 29, 2014
Date of Event: July 8, 2014
Report Date: July 8, 2014
Manufacturer: CONVATEC, INC.
Product Code: KNT
PMA / PMN Number: K032734
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

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, AS THE DEVICES WERE USED DURING A DEMONSTRATION AND NOT ON PTS. PLEASE NOTE: THERE ARE TWO (2) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER CASE. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014. 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 DURING A FLEXI-SEAL SIGNAL DEMONSTRATION THE WATER BALLOON EXPERIENCED BLOCKAGE, THE WATER (45 ML) GOT INTO THE BALLOON BUT WOULD NOT COME OUT ANYMORE FOR IT LOOKED LIKE THE VACUUM WAS NOT THERE. IF IS FURTHER REPORTED THAT DURING THE DEMONSTRATION TEN (10) NURSES COULD PRACTICE AND TWO (2) TIMES THE FMS BLOCKED. LASTLY, THE SYSTEM WAS CHECKED FOR A LEAK BUT COULD NOT FIND ANY, AFTER A FEW SECONDS THE BALLOON COULD BE EMPTIED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
442724	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT	GASTROINTESTINAL TUBE AND ACCESSORIES	KNT	CONVATEC, INC.	418000	13VM516883

Patients

Seq	Age	Sex	Outcome	Treatment
1