CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

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.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, A LEAKAGE OF MEDICAL FLUID FROM THE TUBING WAS OBSERVED. THE SPECIFIC LEAKING SPOT WAS UNABLE TO BE IDENTIFIED. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

REPORT SOURCE: UPDATED H4: DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED D4: DEVICE SERIAL NUMBER/LOT NUMBER IS UNKNOWN H6: HEALTH IMPACT AND EVALUATION CODES: UPDATED NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A PRODUCT SAMPLE AND TWO (2) PICTURES WERE RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. VISUAL INSPECTION FOUND NO DAMAGES DETECTED. FUNCTIONAL TESTING FOUND LEAKAGE WAS DETECTED IN THE CONNECTION BETWEEN EXTENSION TUBE AND FEMALE LUER. THE COMPLAINT IS CONFIRMED. AN INTERNAL CAPA WAS OPENED ON (B)(6) 2022 TO INVESTIGATE AND DETERMINE THE ROOT CAUSE OF THE FAILURE IN LEAK BETWEEN TUBE AND FEMALE LUER SOLVENT BONDING. CURRENTLY CAPA IS IN IDENTIFIED PHASE. ACTIONS TAKEN WILL BE STATED BY CAPA. HOWEVER, ALL MITIGATIONS ARE PLACED IN PROCESS AND PRODUCTION PERSONNEL WERE NOTIFIED ABOUT THE LEAK IN THE SOLVENT UNION BETWEEN FEMALE LUER AND TUBE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4).