CADD INFUSION DISP PORTFOLIO WITH NRFIT CONNECTORS

Additional Manufacturer Narrative

OTHER TEXT: ADDITIONAL INFORMATION H6, H10 . THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. ONE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING, IN USED CONDITION, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL INSPECTION WAS PERFORMED AT 12 TO 16 INCHES UNDER NORMAL CONDITIONS OF ILLUMINATION. VISUAL INSPECTION DID NOT PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, CUTS, ETC. THAT COULD CAUSE THE FAILURE MODE REPORTED. DURING THE FUNCTIONAL TESTING THE SAMPLE WAS FILLED WITH COLORED WATER USING A SYRINGE TO DETECT ANY LEAKAGE. THE TEST CONFIRMED A LEAKAGE NEAR THE NECK OF THE BAG. THE ROOT CAUSE WAS RELATED TO THE MANUFACTURING PROCESS. ACTION TAKEN INCLUDED UPDATING THE PROCEDURE TO PROVIDE ADEQUATE FLOW IN THE EXECUTION OF THE MANUFACTURING ACTIVITIES., CORRECTED DATA: D1, D2.

Description of Event or Problem

INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS LEAKAGE OF MEDICAL FLUID WAS NOTICED. IT WAS REPORTED THAT AFTER FINISHING THE USE OF THE PRODUCT, THE CUSTOMER FOUND LEAKAGE OF MEDICAL FLUID AND NOTICED NO AMOUNT OF MEDICAL FLUID WAS ADMINISTERED. NO PATIENT INJURY REPORTED.