FDA Adverse Event Malfunction Summary report: N

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT

MDR report key: 4121560 · Received July 29, 2014

Report

Report Number: 1049092-2014-00357
Event Type: Malfunction
Date Received: July 29, 2014
Date of Event: July 9, 2014
Report Date: July 9, 2014
Manufacturer: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.
Product Code: KNT
PMA / PMN Number: K032734
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

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. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. 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 UPON TRANSFER OF THE PATIENT FOR DISCHARGE RELATED TO SELECT SPECIALITY, THE FLEXI-SEAL WAS LEAKING SO REMOVAL WAS ATTEMPTED BY EXTRACTING THE 45CC OUT OF THE PORT, BUT THERE WAS NO WATER IN IT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS INSTRUCTED TO BEAR DOWN AND WHEN THE TIP CAME OUT IT WAS COMPLETELY FILLED WITH WATER. LASTLY, REPORT STATES THAT TWO (2) OTHER RNS WERE AT PATIENT'S BEDSIDE TO TROUBLESHOOT, AFTER REMOVAL DEFLATION WAS TRIED AGAIN, BUT IT WOULD NOT DEFLATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
442719	FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM KIT	GASTROINTESTINAL TUBE & ACCESSORIES	KNT	CONVATEC, A DIVISION OF E.R. SQUIBB & SONS L.L.C.	418000	14VM533172

Patients

Seq	Age	Sex	Outcome	Treatment
1