CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

Additional Manufacturer Narrative

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 IN USED CONDITIONS WITH ITS ORIGINAL OPEN PACKAGING. SAMPLE COULD NOT BE TESTED DUE WHEN THE SYRINGE WAS REMOVED AND THE TIP WAS BROKEN INSIDE THE CONNECTOR, HOWEVER THE COMPLAINT IS CONFIRMED BY PICTURES ATTACHED. THE MOST PROBABLE ROOT CAUSE IS THAT THE CASSETTE WITH LEAK IN THE BONDING JOINS WAS NOT PROPERLY SEGREGATED DURING LEAK TEST OPERATION AT THE MOMENT TO RE-TEST THE PARTS. A CORRECTIVE AND PREVENTATIVE ACTION WAS OPENED TO ADDRESS THE REPORTED ISSUE.

Description of Event or Problem

INFORMATION WAS RECEIVED THAT DURING USE OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS, THE LEAKING OF MEDICAL FLUID WAS NOTICED BY THE CUSTOMER. NO PATIENT INJURY REPORTED.