V. MUELLER

Additional Manufacturer Narrative

STERIS REQUESTED THE CHROMA-LINE BRAND TAKA SUCTION TUBE SUBJECT OF THE REPORTED EVENT BACK FOR EVALUATION. THE INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MW5174574 REPORT THAT, "SUCTION BROKE INTO TWO PIECES WHILE IN USE, BOTH PIECES RETRIEVED." NO REPORT OF INJURY.

Additional Manufacturer Narrative

STERIS REQUESTED THE CHROMA-LINE BRAND TAKA SUCTION TUBE SUBJECT OF THE REPORTED EVENT BACK FOR EVALUATION HOWEVER, THE DEVICE WAS NOT RETURNED. WITHOUT THE RETURN OF THE DEVICE THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. AS THE USER FACILITY DESCRIBED THE DEVICE BREAKING INTO TWO PIECES IN THE REPORTED EVENT, THE CAUSE MAY BE ATTRIBUTED TO EXCESSIVE FORCE APPLIED TO THE CHROMA-LINE BRAND TAKA SUCTION TUBE DURING USE. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED NO ABNORMALITIES WERE NOTED. A COMPLAINT REVIEW WAS PERFORMED AND CONFIRMED THE EVENT TO BE ISOLATED FOR THE SUBJECT LOT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.