FDA Adverse Event Malfunction Summary report: N

CUROS DISINFECTING PORT PROTECTOR

MDR report key: 4333601 · Received September 27, 2014

Report

Report Number: 3008142801-2014-00002
Event Type: Malfunction
Date Received: September 27, 2014
Date of Event: August 3, 2014
Report Date: August 15, 2014
Manufacturer: IVERA MEDICAL
Product Code: LKB
PMA / PMN Number: K111992
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

MDR WAS OBSERVED WHEN CONDUCTED A SEARCH OF FDA'S MAUDE DATABASE ON SEPTEMBER 25, 2014. NO OTHER NOTIFICATION WAS PROVIDED BY THE USER FACILITY NOR (B)(4)'S SALE REPRESENTATIVES. THE REPORTED DEVICE WAS NOT RETURNED BY THE USER FACILITY NOR WAS THE LOT NUMBER COMMUNICATED. WITHOUT THE DEVICE OR LOT NUMBER, (B)(4) IS NOT ABLE TO INVESTIGATED THE REPORTED ISSUE. (B)(4) COULD NOT CONTACT THE USER FACILITY SINCE CONTACT INFORMATION FROM THE USER FACILITY WAS INDICATED IN THE REPORTED INFORMATION. (B)(4) 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

CUROS CAP BROKE APART. LITTLE GREEN RING STAYED ON THE IV PORT WHEN RN TOOK THE CAP OFF. THIS APPARENTLY HAPPENED TWICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
603431	CUROS DISINFECTING PORT PROTECTOR	NONE	LKB	IVERA MEDICAL	002-250

Patients

Seq	Age	Sex	Outcome	Treatment
1