3.5FR URETHANE UMB 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 SINGLE A LUMEN UVC PLACED. IT WAS NOTED TO BE LEAKING AT THE JUNCTION OF THE CATHETERS AND THE HARD PLASTIC HUB.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED. ONE USED CATHETER WITH AN UNKNOWN LOT NUMBER WAS RECEIVED INSIDE OF A GENERIC PLASTIC BAG FOR ANALYSIS. ACCORDING TO THE VISUAL INSPECTION, THE CATHETER SHOWED SIGNS OF USE SUCH AS BLOOD AND IT WAS RETURNED WITH AN ADDITIONAL EXTENSION THAT DOES NOT BELONG TO THE ORIGINAL PRODUCT. IN ADDITION, IT WAS OBSERVED THAT THE CATHETER HAD BEEN PREVIOUSLY MANIPULATED AS IT APPEARED TO BE CUT AND CONTAINS A GREEN ADAPTER AND THE EXTENSION HAS A METALLIC OBJECT. THE REPORTED CONDITION COULD NOT BE CONFIRMED SINCE THE DEVICE COULD NOT BE TESTED FOR LEAKING TESTING BECAUSE OF THE CONDITION OF THE SAMPLE. THE CONDITION REPORTED MOST LIKELY OCCURRED AS A RESULT OF MANIPULATING THE DEVICE DURING USE. 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.