CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRODUCT, THE CONNECTION PART WAS FOUND TO BE DAMAGED AND LOOKED LIKE IT WAS CRACKED. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A PRODUCT SAMPLE AND THREE PICTURES WERE RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. VISUAL INSPECTION FOUND CRACKS IN THE FEMALE LUER. FUNCTIONAL TESTING FOUND THE CRACK IN FEMALE LUER COULD BE REPLICATED ONLY UNDER ABNORMAL CONDITIONS OF USE. THE CRACKS ONLY COULD BE REPLICATED USING AN ADDITIONAL TOOL THAT HELPED TO APPLY EXCESSIVE FORCE; COMPRESSION TWEEZERS WAS USED TO GRIP THE FEMALE LUER IN THE BASE, THE FEMALE LUER WAS MOVED IN DIFFERENT DIRECTIONS (UP AND DOWN) TO TRY CAUSE THE CRACK. A CRACK IN THE FEMALE LUER WAS CREATED BUT TO REPLICATE EXCESSIVE COMPRESSION NEEDS TO APPLICATED TO THE FEMALE LUER, THE FEMALE LUER WAS DEFORMED IN THE PROCESS. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNDETERMINED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).