NDEHP MICR YTYPE CLV

Additional Manufacturer Narrative

THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 381304W. A REP DEVICE FROM THE SAME LOT NUMBER WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem

THE CUSTOMER CONTACT REPORTED BREAKAGE OF THE DISTAL TIP OF THE SPIN-LOK MALE ADAPTER. IT WAS REPORTED THAT THE SPIN-LOK MALE ADAPTER OF THE Y-TYPE MICROBORE EXTENSION TUBING SET WAS CONNECTED TO AN UNSPECIFIED CLAVE PORT OF THE PLUMSET FOR THE DELIVERY OF AN UNSPECIFIED CONCENTRATION OF FENTANYL AND OTHER UNSPECIFIED MEDICATIONS. NO SPECIFIC DETAILS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE NURSE ATTEMPTED TO CHANGE THE PT'S IVS AND DISCONNECTED THE DISTAL TIP OF THE SPIN-LOK MALE ADAPTER FROM THE CLAVE PORT OF THE PLUMSET. AT THIS TIME, THE CUSTOMER CONTACT REPORTED THAT THE DISTAL TIP OF THE SPIN-LOK MALE ADAPTER BROKE OFF AND A PIECE REMAINED LODGED INSIDE THE CLAVE PORT OF THE PLUMSET. IT WAS REPORTED THAT APPROX LESS THAN 50ML OF THE PT'S BLOOD LEAKED; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS. IT WAS REPORTED THAT THE NURSE CLAMPED THE PRIMARY PLUMSET. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WAS NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADD'L INFO WAS PROVIDED.