ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER SINGLE LUMEN

Description of Event or Problem

RECEIVED AN EMAIL FROM ECRI [EMERGENCY CARE RESEARCH INSTITUTE] THAT STATED: "IN A [DATE REDACTED], URGENT MEDICAL DEVICE PRODUCT RECALL LETTER SUBMITTED BY ECRI MEMBER HOSPITALS, (B)(6) STATES THAT THERE MAY BE A PACKAGING DEFECT IN THE OUTER TYVEC POUCH THAT PROTECTS THE ABOVE STERILE PRODUCTS. THIS POUCH IS USED ON BOTH THE SINGLE-STERILE UMBILICAL VESSEL CATHETERS AND THE PRODUCT WITHIN A FINISHED INSERTION TRAY. THIS DEFECT MAY ALLOW FOR SMALL HOLES TO DEVELOP IN THE POUCH, WHICH COULD COMPROMISE THE STERILITY OF THE PRODUCT. THESE HOLES MAY BE UNDETECTABLE UPON VISUAL INSPECTION, SO NONE OF THE IDENTIFIED LOTS SHOULD BE USED. (B)(6) ALSO STATES THAT IF THERE IS A BREACH IN THE STERILE PACKAGING, THERE IS A RISK THAT A NONSTERILE PRODUCT COULD BE USED ON A PATIENT, INCREASING THE RISK OF UNSPECIFIED INFECTION. THIS INFECTION WOULD BE SEVERE IN NATURE, CAUSING MAJOR HEALTH IMPACTS TO THE PATIENT AS EXPOSURE WOULD OCCUR INTRAVASCULARLY, LEADING TO WIDESPREAD INFECTION OR POTENTIALLY DEATH IN A HIGH-RISK PATIENT POPULATION. (B)(6) FURTHER STATES THAT IT HAS RECEIVED NO REPORTS OF HARM OR ADVERSE EVENTS ASSOCIATED WITH THE USE OF AFFECTED PRODUCT. THE MANUFACTURER HAS NOT CONFIRMED THE INFORMATION PROVIDED IN THE SOURCE MATERIAL. ACTION NEEDED: IDENTIFY, ISOLATE, AND DISCONTINUE USE OF ANY AFFECTED PRODUCT IN YOUR INVENTORY." PATIENT HAD A 5 FR UMBILICAL LINE PLACED ON [DATE REDACTED]. ALL 5FR UMBILICAL CATHETERS IN THE NICU ON [DATE REDACTED] WERE AMONG THE AFFECTED LOT NUMBERS AND WERE REMOVED.