FDA Adverse Event Other Summary report: N

NONE

MDR report key: 1576602 · Received December 28, 2009

Report

Report Number: 3005011024-2009-00002
Event Type: Other
Date Received: December 28, 2009
Product Code: EFQ
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEROYAL CONTACTED THE OUTSIDE VENDOR OF THE GAUZE AND REQUESTED AN INVESTIGATION INCLUDING A WRITTEN REPORT AT ITS CONCLUSION. THE VENDOR HAS ADVISED THAT A THOROUGH INVESTIGATION WAS CONDUCTED AND THEIR PRODUCTION AND QUALITY ASSURANCE PERSONNEL CONDUCTED A ROOT CAUSE ANALYSIS. THE ANALYSIS CONCLUSION IS THAT THE FRAYING POSSIBLY HAPPENED AT THE SLITTING PROCESS. WHEN THE JUMBO ROLLS OF COTTON ARE SLICED INTO SMALLER ROLLS, A BLADE IS USED AND WHEN THE BLADE BECAME BLUNT WITH USE, MORE LINT MAY HAVE GENERATED AT THE EDGE OF THE SMALL ROLLS. THE SMALL ROLLS WITH FRAYED EDGES WERE THEN LATER FOLDED INTO FINISHED GAUZE. LINT FIBERS MIGHT ALSO POSSIBLY ORIGINATE FROM THE CUTTING BLADE OF THE FOLDING MACHINE ITSELF. DURING THE FOLDING PROCESS; THE LOOSE FIBER MAY FALL ONTO THE GAUZE AND BE FOLDED INTO THE FINISHED PRODUCT. THE VENDOR'S ENGINEERING DEPARTMENT HAS IMPROVED THE MFG PROCESS. THE ROTARY BLADE USED FOR SLITTING THE JUMBO ROLL WAS REPLACED WITH A BAND TYPE SAW TO MINIMIZE THE LINT GENERATED AND MINIMIZE THE FRAYING OF THE EDGES OF THE GAUZE. THE CLEANING FREQUENCY OF THE FOLDING MACHINE WAS INCREASED AND IS TO BE MONITORED FOR EFFECTIVENESS BY THE VENDOR'S QA STAFF AND ALL COMPLAINTS ARE TO BE TRENDED FOR ANALYSIS.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		NONE	EFQ

Patients

Seq	Age	Sex	Outcome	Treatment
1