FDA Adverse Event Malfunction Summary report: N

CUROS DISINFECTING PORT PROTECTOR

MDR report key: 4197148 · Received September 27, 2014

Report

Report Number: 3008142801-2014-00001
Event Type: Malfunction
Date Received: September 27, 2014
Date of Event: July 11, 2014
Report Date: July 15, 2014
Manufacturer: IVERA MEDICAL
Product Code: LKB
PMA / PMN Number: K111992
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

NOTIFICATION OF THE MDR WAS PROVIDED THROUGH A LETTER FROM THE FDA DATED ON (B)(4) 2014. THE LETTER WAS RECEIVED AT IVERA ON (B)(4) 2014. THE REPORTED DEVICE WAS NOT RETURNED BY THE USER FACILITY NOR WAS THE LOT NUMBER COMMUNICATED. WITHOUT THE DEVICE OR LOT NUMBER, IVERA IS NOT ABLE TO INVESTIGATED THE REPORTED ISSUE. CONTACT WAS MADE WITH THE USER FACILITY, WHICH THEY INDICATED THAT ISSUES WERE MINOR AND NON-SIGNIFICANT. THERE WAS NO PATIENT OF SAFETY RELATED INCIDENT AND THEY HAVE NOT HAD ANY ADDITIONAL ISSUES SINCE THE RECENT REPORTS. IVERA DID REVIEW VERIFICATION REQUIREMENTS THAT ARE CONDUCTED IN MANUFACTURING OF THE PRODUCT. SAMPLING IS CONDUCTED ON A CONTINUOUS PERIODIC BASIS, WHICH TENSILE VERIFICATION IS PART OF INSPECTION TO CONFIRM THAT A MINIMUM RETENTION FORCE WHEN ENGAGED WITH A NEEDLELESS LUER ACTIVATED VALVE (LAV). MANUFACTURING LIMITS ARE ESTABLISHED ON THE MANUFACTURING EQUIPMENT, WHICH IS MONITORED REAL-TIME. IF AN EXCURSION OCCURS OUTSIDE THE MANUFACTURING LIMITS, THE MANUFACTURING EQUIPMENT WILL AUTOMATICALLY SEGREGATE PRODUCT PRODUCED AT THE TIME THE EXCURSION OCCURS.

Description of Event or Problem · 1

THE CUROS CAPS ARE BREAKING WHILE PATIENTS ARE MOVING AROUND IN BED AND ALSO BREAK APART AS THE NURSE REMOVES THE CAP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
604249	CUROS DISINFECTING PORT PROTECTOR	NONE	LKB	IVERA MEDICAL	002-250

Patients

Seq	Age	Sex	Outcome	Treatment
1