CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

Additional Manufacturer Narrative

A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRODUCT, LEAKAGE OF MEDICAL FLUID FROM THE CONNECTION PART WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

OTHER, OTHER TEXT: H10: DEVICE EVALUATION: ONE SAMPLE WAS RETURNED FOR INVESTIGATION. THE SAMPLE CONSISTED OF ONE LUER WITH AN EXTENSION PRODUCT; THE SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. THE SAMPLE WAS VISUALLY INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT CONDITIONS THAT COULD CAUSE FUNCTIONAL ISSUES. NO DAMAGE WAS DETECTED IN THE SAMPLE. A LEAK TEST WAS CONDUCTED, AND A LEAKAGE WAS DETECTED IN THE CONNECTION BETWEEN THE EXTENSION TUBE AND THE FEMALE LUER. THE COMPLAINT WAS CONFIRMED. THE SAMPLE WAS BROKEN IN THE FEMALE LUER TO REVIEW IF THERE WAS ANY ISSUE WITH THE BONDING; IT WAS FOUND THAT THE TUBE WAS NOT FULLY INSERTED IN THE LUER. A CAPA WAS OPENED TO INVESTIGATE THE REPORTED ISSUE AND TO DETERMINE THE ROOT CAUSE OF THE LEAK BETWEEN THE TUBE AND THE FEMALE LUER SOLVENT BONDING. CAPA IS CURRENTLY IN THE IDENTIFIED PHASE. NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4)., CORRECTED DATA: CORRECTION: NO LOT/SERIAL NUMBER WAS PROVIDED, THEREFORE THE PRODUCT MANUFACTURE OR EXPIRATION DATE WAS UNKNOWN.