FDA Adverse Event Malfunction Summary report: N

SECURE

MDR report key: 11925131 · Received June 2, 2021

Report

Report Number: 1937141-2021-00009
Event Type: Malfunction
Date Received: June 2, 2021
Report Date: June 2, 2021
Manufacturer: THE METRIX COMPANY
Product Code: KPE
UDI-DI: 20812496011477
PMA / PMN Number: K960581
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS DONE AND A CLEAR/WHITE FIBER-LIKE PARTICULATE WAS IDENTIFIED WITHIN THE FILLED BAG. THE UNIT WAS SENT TO AN EXTERNAL LAB FOR ANALYSIS OF THE PARTICULATE AND THE RESULTS SHOW THE CLOSEST MATCH TO POLYETHYLENE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE QUALITY CONTROL INSPECTION OF THIS LOT. THE CAUSE OF THE CONDITION IS BEING INVESTIGATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A FLOATER WAS FOUND INSIDE A SECURE EVA DUAL CHAMBER 1500 ML BAG WITH 5 PORT MANIFOLD FILL SET. IT WAS FURTHER REPORTED THAT THE FLUID WAS FILTERED WITH A 0.2 MICRON FILTER, THE INTEGRITY TEST PASSED AND NO NEEDLE PUNCTURES WERE MADE TO THE BAG. THE FLOATER WAS NOTED BY THE PHARMACY DURING THE VISUAL INSPECTION OF THE FILLED BAG AT THE PACKAGING BENCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
822741	SECURE	1500 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET	KPE	THE METRIX COMPANY	66616	66616-A6877	20812496011477

Patients

Seq	Age	Sex	Outcome	Treatment
1