MDR event

Additional Manufacturer Narrative

AN INVESTIGATION OF THE REPORTED CONDITION WAS PERFORMED. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR E VALUATIONS. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. SINCE NO SAMPLE WAS RETURNED FOR EXAMINATION, IT WAS NOT POSSIBLE TO EVALUATE IT AS PART OF A COMPREHENSIVE INVESTIGATION. THE REPORTED CONDITION IS NOT CONFIRMED. AS NO LOT NUMBER WAS IDENTIFIED, A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW OR PRODUCT/PROCESS CHANGES REVIEW FOR THE INVOLVED LOT NUMBER COULD NOT BE PERFORMED. HOWEVER, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. THE AVAILABLE INFORMATION WAS ANALYZED AND IT DID NOT ALLOW CONFIRMING A ROOT CAUSE FOR THE EVENT. THE FOLLOWING POTENTIAL CAUSES WERE IDENTIFIED: MACHINE MALFUNCTION, CUSTOMER MISUSE, FAILED IN PROCESS, DEFECTIVE MATERIAL, SHARPS USAGE WITH CATHETER. NO TRENDS OR TRIGGERS HAVE BEEN FOUND. THEREFORE, A CORRECTIVE OR PREVENTIVE ACTION IS NOT DEEMED NECESSARY AT THIS TIME. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

SUBMIT DATE: 05/31/2017. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER STATES THAT THE UMBILICAL VESSEL CATHETER DEVELOPED HOLES NEAR THE UMBILICUS; THIS LED TO HYPOGLYCEMIA.