CLINITUBES

Description of Event or Problem

WHEN THE USER (TECHNICIAN) WAS DRAWING BLOOD FROM AN INFANT THE CAPILLARY BROKE WHEN THE END CAP WAS BEING PUT ON. THE USERS LEFT MIDDLE FINGER WAS PUNCTURED. GLOVES WERE WORN. THE REPORT STATES THAT THE USER WAS TREATED AND RELEASED FROM THE ED AND SENT HOME. NO SPECIFIC INFORMATION REGARDING THE TREATMENT WAS GIVEN.

Additional Manufacturer Narrative

THE FOLLOWING INFORMATION WAS FOUND DURING AN INTERNAL REVIEW AT RADIOMETER MEDICAL ON (B)(6) 2017; INFORMATION ABOUT THE POTENTIAL RISK OF INFECTION FROM THE PATIENT HAS BEEN RECEIVED FROM THE CUSTOMER, WHICH STATES THAT THE PATIENT WAS NOT IN ISOLATION FOR ANYTHING CONTAGIOUS.

Additional Manufacturer Narrative

TEST OF THE BREAKING FORCE OF CLINITUBES FROM THE REFERENCE STOCK OF LOT JV-02 HAS BEEN PERFORMED AND COMPARED TO THE BREAKING FORCE OF THE PREVIOUS AND FOLLOWING LOTS PRODUCED (JW-01 AND JT-01). THE BREAKING FORCE OF LOT JV-02 WAS NOT STATISTICALLY DIFFERENT FROM THE BREAKING FORCE OF LOT JW-01 OR JT-01, AND NO OTHER COMPLAINTS REGARDING THIS LOT HAVE BEEN RECEIVED. SINCE THESE CLINITUBES ARE MADE OF GLASS THERE IS A RISK THAT THEY CAN BREAK. THE HOSPITAL HAS NOW CHANGED TO USE SAFE CLINITUBES (MADE OF PLASTIC) TO AVOID THIS PROBLEM IN THE FUTURE. INFORMATION ABOUT THE POTENTIAL RISK OF INFECTION FROM THE INFANT HAS BEEN REQUESTED BUT NOT YET RECEIVED.