FDA Adverse Event Summary report: N

PREMICATH

MDR report key: 4722185 · Received April 20, 2015

Report

Report Number: 2245270-2015-00037
Date Received: April 20, 2015
Date of Event: March 23, 2015
Report Date: April 20, 2015
Manufacturer: VYGON GMBH
Product Code: LJS
PMA / PMN Number: K041468
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THERE WAS ONE ADDITIONAL OCCURRENCE OF THIS CAUSE OF CONDITION IN THIS PRODUCT LOT. PLEASE REFERENCE THE FOLLOWING MDR FOR ADDITIONAL INFO: MDR# 2245270-2014-00036. AT THIS MOMENT, VYGON CONTINUES TO INVESTIGATE THE COMPLAINT BUT IS UNABLE TO DETERMINE A ROOT CAUSE. THIS INCLUDES, BUT IS NOT LIMITED TO, INVESTIGATION OF THE RAW MATERIAL AND RAW MATERIAL DEVELOPMENT, THE MANUFACTURING PROCESS OF THE CATHETER, AND STERILIZATION. THERE HAS BEEN NO CHANGE TO ANY MATERIAL OR PROCESS. IT IS UNDETERMINED AT THIS TIME IF THE PRODUCT IS NON-CONFORMING, OR IF THE CAUSE IS A RESULT OF CLINICAL USE. MOVING FORWARD, VYGON WILL BE USING A SIMILAR MARKET CLEARED MATERIAL FOR ALL PREMICATH CODES. THIS MATERIAL IS CURRENTLY ONLY USED IN PREMICATH 1261.20G CLEARED UNDER K954302. THIS MATERIAL HAS A GREATER TENSILE STRENGTH AND PERFORMS BETTER IN CONJUNCTION WITH THE USE OF ORGANIC SOLVENTS USED FOR SITE PREP. THIS MATERIAL IS ALREADY FULLY VALIDATED FOR USE IN ALL CATHETER CODES AS ALL CATHETERS ARE IDENTICAL, THE ONLY DIFFERENCE BEING THE COMPONENTS OF INSERTION.

Description of Event or Problem · 1

PICC LINE LEAKED FROM THE HUB WHILE INFUSING. PICC WAS REMOVED, AND A NEW LINE WAS INSERTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
259081	PREMICATH	LONG TERM INTRAVASCULAR CATHETER	LJS	VYGON GMBH	1261.203G	230414GC

Patients

Seq	Age	Sex	Outcome	Treatment
1	18 DA