NDEHP MICR YTYPE CLV
Received Jun 26, 2014 · Event occurred May 28, 2014
Report 9613251-2014-00115 · MDR key 3959772
Device
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED BREAKAGE OF THE DISTAL TIP OF THE SPIN-LOK MALE ADAPTER. AT AN UNSPECIFIED TIME, A PLUMSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, VIA THE PT'S PERIPHERAL ACCESS DEVICE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE SPIN-LOK MALE ADAPTER OF THE MICROBORE EXTENSION TUBING SET WAS CONNECTED TO THE DISTAL CLAVE Y-SITE OF THE PLUMSET FOR THE PIGGYBACK DELIVERY OF AN UNSPECIFIED SOLUTION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT WHEN THE NURSE ATTEMPTED TO DISCONNECT THE SPIN-LOK MALE ADAPTER FROM THE CLAVE PORT, THE DISTAL TIP OF THE SPIN-LOK MALE ADAPTER BROKE OFF INTO THE DISTAL CLAVE PORT OF THE PLUMSET AND A PIECE REMAINED LODGED INSIDE THE CLAVE PORT OF THE PLUMSET. NO SPECIFIC DETAILS WERE PROVIDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF CRITICAL THERAPY. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
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 WILL BE EVALUATED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.