CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

Description of Event or Problem

IT WAS REPORTED THAT MOISTURE WAS DISCOVERED IN THE BAG, AFTER FILLING CASSETTE AND PACKING INSIDE THE BAG. UPON INSPECTION, IT TURNED OUT THAT THERE WAS A LEAK. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. TWO SAMPLES WERE RECEIVED WITHOUT THEIR ORIGINAL PACKAGING, INSIDE A PLASTIC BAG. DURING THE VISUAL INSPECTION, THE SAMPLES DID NOT PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, CUTS, ETC. THAT COULD CAUSE THE FAILURE MODE REPORTED, HOWEVER SOME COMPONENTS ARE MISSING, THE BLUE CLIP, THE SPRING, AND THE GREEN ARM. SINCE THERE WERE MISSING COMPONENTS IN THE SAMPLES RETURNED NO FUNCTIONAL TEST CAN BE PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE SAMPLES WERE RECEIVED WITH MISSING COMPONENTS AND LOOKED LIKE THEY WERE MANIPULATED DURING USE. NO ACTIONS TAKEN SINCE THE COMPLAINT COULD NOT BE REPLICATED.