INFANT HEEL WARMER,SQUEEZE, 4X4IN

Description of Event or Problem

CUSTOMER REPORTED THAT WHILE A BLOOD DRAW WAS BEING PERFORMED IN AN OUTPATIENT LAB, A TEAM MEMBER ATTEMPTED TO USE AN INFANT HEEL WARMER. THE TEAM MEMBER POINTED THE PACK AWAY FROM PATIENT AND MEMBER AND ACTIVATED THE WARMER BY SQUEEZING. THE PACK SQUIRTED OUT FLUID, BUT IT DID NOT LAND ON PATIENT OR ON TEAM MEMBER. THERE WAS NO INJURY REPORTED.

Additional Manufacturer Narrative

BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED ON THE REPORTED LOT NUMBER, V1P119. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED AND RELEASED TO PREDETERMINED SPECIFICATIONS WITH NO ANOMALIES FOUND. ONE SAMPLE WAS RECEIVED ON 2/15/2022 THAT WAS ALREADY ACTIVATED. THE ROOT CAUSE WAS DETERMINED TO BE TOP SEAL RUNOFF DUE TO INADEQUATE PROCEDURE. THE SITE HAS UPDATED THE PROCEDURE FOR THE OPERATORS TO ENSURE THEY ARE VERIFYING & DOCUMENTING THAT THE SYSTEM IS WORKING PROPERLY ON EACH MACHINE DURING MANUFACTURING. ADDITIONALLY, THE MANUFACTURING PLANT WILL CONTINUE TO MONITOR THIS ISSUE THROUGH ROUTINE COMPLAINT TREND ANALYSIS.