INTERLINK

Description of Event or Problem

IT WAS REPORTED THAT A INTERLINK SYSTEM NON DEHP MINIVOLUME EXTENSION SET WAS DETACHED FROM THE FILTER CONNECTED TO THE LUMEN, RESULTED IN BLOOD BACKFLOW INTO THE PERIPHERALLY INSERTED CENTRAL CATHETER LINE (PICC). BLOOD WAS OBSERVED IN THE WHITE LUMEN OF THE PICC LINE, WITH BACKFLOW UP TO THE FILTER. THE FILTER WAS REMOVED, AND AN ATTEMPT WAS MADE TO FLUSH THE LINE; HOWEVER, FLUSHING WAS UNSUCCESSFUL, AND A CLOT WAS OBSERVED IN THE CAP. TPA (TISSUE PLASMINOGEN ACTIVATOR) WAS INSTILLED TO RESOLVE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D4: UNIQUE DEVICE IDENTIFIER (UDI) # IS BASED ON THE DI INFORMATION AS NO LOT NUMBER WAS PROVIDED BY THE REPORTER. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.