SECONDARY SET C62
Received Oct 13, 2023 · Event occurred Oct 3, 2023
Report 3003152976-2023-00466 · MDR key 17930756
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
LEAKAGE HAPPENED DURING INFUSION, PLEASE WATCH THE VIDEO ATTACHED. 04-OCT-2023 - RECEIVED EMAIL REPLY FROM COMPLAINANT FOR ADDITIONAL INFORMATION LEAKAGE HAPPENED DURING PRIMING, BEFORE USE ON PATIENT.
Additional Manufacturer Narrative
PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: VIDEOS WHICH DISPLAY THE REPORTED DEVICE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, A DROP OF LIQUID BETWEEN THE TUBING AND THE SPIKE IS OBSERVED, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF LOT TA12171, ALL PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. TEN RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND IN ALL CASES THE PRODUCT PERFORMED AS INTENDED AND NO LEAKAGE OCCURRED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE. ALL TESTING WAS REVIEWED FOR THE REPORTED LOT, INCLUDING LEAKAGE, TORQUE, AND INSPECTION RESULTS WITH NO ISSUES IDENTIFIED RELATED TO THE REPORTED MALFUNCTION. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THIS INCIDENT OCCURRED DUE TO UNEVEN DISTRIBUTION OF THE SOLVENT USED TO JOIN THE SPIKE AND TUBING BY PERSONNEL OR AN ISSUE WITH THE MATERIAL USED TO MANUFACTURE THE DEVICE. WITHOUT THE PHYSICAL SAMPLE AND GIVEN THE RETAINED SAMPLES DID NOT DISPLAY ANY LEAKAGE, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.
Additional Manufacturer Narrative
(B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A050401 - FLUID/BLOOD LEAK. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT.
Description of Event or Problem
LEAKAGE HAPPENED DURING INFUSION, PLEASE WATCH THE VIDEO ATTACHED. (B)(6) 2023 - RECEIVED EMAIL REPLY FROM COMPLAINANT FOR ADDITIONAL INFORMATION LEAKAGE HAPPENED DURING PRIMING, BEFORE USE ON PATIENT.