FDA Adverse Event Malfunction Summary report: N

MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

MDR report key: 4781801 · Received April 16, 2015

Report

Report Number: 2020394-2015-00488
Event Type: Malfunction
Date Received: April 16, 2015
Report Date: March 26, 2015
Manufacturer: BARD PERIPHERAL VASCULAR, INC.
Product Code: KNW
PMA / PMN Number: K922939
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE LOT NUMBER HAS BEEN PROVIDED AND THE LOT DEVICE HISTORY RECORDS HAVE BEEN REVIEWED THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THE DEVICE WAS RETURNED HALF PRIMED, WITH THE CANNULA RETRACTED, EXPOSING THE SAMPLE NOTCH. LOOSE PARTICLES COULD BE HEARD WITHIN THE DEVICE. THERE WERE NO VISUAL ANOMALIES NOTED ON THE SAMPLE. THE SAMPLE WAS TESTED BY ATTEMPTING TO TWIST THE ROTATIONAL KNOB ONCE HOWEVER THE DEVICE WOULD NOT PRIME. FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE DEVICE COULD NOT BE FULLY PRIMED. THE SAMPLE WAS DISASSEMBLES AND THE INTERNAL COMPONENTS WERE EXAMINED. THE CANNULA HUB WAS FOUND TO BE BROKEN. THE INVESTIGATION IS CONFIRMED FOR A BREAK, AS THE CANNULA HUB WAS FOUND TO BE BROKEN. THE INVESTIGATION IS INCONCLUSIVE FOR FAILURE TO FIRE, AS THE DEVICE COULD NOT BE FUNCTIONALLY TESTED DUE TO THE BROKEN COMPONENTS. THE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE SUPPLIER RELATED DUE TO OVER-PROCESSED RESIN.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PROBE FAILED TO FIRE DURING THE US GUIDED BREAST BIOPSY AFTER BEING FULLY PRIMED. A COAXIAL WAS USED DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
256272	MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT		KNW	BARD PERIPHERAL VASCULAR, INC.		REYI2147

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR