INTERLINK

Additional Manufacturer Narrative

D4 UDI: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. 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.

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP MINIVOLUME EXTENSION SET LEAKED FROM THE "RUBBER PORT ON THE MED LINE FILTER" (INTERLINK COMPONENT) DURING A MAGNESIUM INFUSION; THE RUBBER STOPPER WAS "HALF OUT". THE PATIENT STILL RECEIVED A MAJORITY OF THE INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.