NDEHP MICR YTYPE CLV
Received Jun 26, 2014 · Event occurred Jan 1, 2014
Report 9613251-2014-00116 · MDR key 3959771
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. A PLUMSET WAS CONNECTED TO THE PT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MAGNESIUM SULFATE, AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THAT THE SPIN-LOK MALE ADAPTER OF THE Y-TYPE MICROBORE EXTENSION TUBING SET WAS CONNECTED TO THE DISTAL CLAVE Y-SITE OF THE PLUMSET. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSE ATTEMPTED A FLUSH PROCEDURE. AT THIS TIME, IT WAS REPORTED THAT THE DISTAL TIP OF THE SPIN-LOK MALE ADAPTER BROKE OFF AND A PIECE REMAINED LODGED INSIDE THE CLAVE Y-SITE. NO SPECIFIC DETAILS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT THE PT'S PICC LINE WAS REPLACED; HOWEVER, THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. 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.