3.5FR DUAL-LUMEN UVC CATH

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

CUSTOMER REPORTS: THE INFANT HAD A DUAL LUMEN UVC PLACED ON ADMISSION. DURING NIGHT SHIFT OF 1/30 IT WAS NOTED TO BE LEAKING AT THE JUNCTION OF THE CATHETER AND THE HARD PLASTIC HUB. THE LINE WAS REMOVED AND SAVED.

Additional Manufacturer Narrative

A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS IDENTIFIED AS UNKNOWN, HOWEVER ALL DHRS ARE REVIEWED TO CONFIRM ALL REGULATORY REQUIREMENTS PRIOR TO PRODUCT RELEASE. ONE USED CATHETER WITH AN UNKNOWN LOT NUMBER AND PRODUCT CODE ID 8888160341 WAS RECEIVED INSIDE OF A GENERIC PLASTIC BAG FOR INVESTIGATION. ACCORDING TO THE TESTING PERFORMED ON THE SAMPLE, VISUALLY IT SHOWS EVIDENCE THAT THE CATHETER WAS USED DUE TO BLOOD RESIDUE AND TWO ADAPTORS THAT WERE INCLUDED AND DO NOT BELONG TO THE ORIGINAL PRODUCT. DURING A LEAK TEST OF THE SAMPLE BUBBLES FORMED BECAUSE OF A BROKEN CATHETER IN THE STRAIN RELIEF. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. AS THE DEVICE WAS ALREADY USED ON THE PATIENT IT HAD ALREADY BEEN FLUSHED PRIOR USE. BASED ON THIS IT IS CONCLUDED THAT WHEN FLUSHING THE DEVICE PRIOR TO INSERTING IT TO THE PATIENT, IT DID NOT SHOW THE REPORTED CONDITION, MEANING THAT THE DEVICE WAS IN GOOD CONDITION PRIOR TO USE. THE CONDITION REPORTED MOST LIKELY OCCURRED BECAUSE OF MANIPULATING THE DEVICE DURING USE. IN ADDITION, IT WAS OBSERVED THAT THE CATHETER HAS PREVIOUS MANIPULATION, DUE TO A CUT AND A GREEN ADAPTER IN THE EXTENSION THAT HAS A METALLIC OBJECT. IT MUST BE NOTED THAT IN-PROCESS CONTROLS SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING ARE PERFORMED IN THE PLANT ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.