UMBILICAL CATHETER
Received Feb 25, 2021 · Event occurred Jan 30, 2021
Report 2245270-2021-00018 · MDR key 11379377
Device
Product problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SPLIT NOTED AT POINT 13. BLOOD OOZING FROM THAT POINT. THE LINE WAS INSERTED (B)(6) 2021 AT 22.00 AND REMOVED ON (B)(6) 2021. LENGTH OF CATHETER INSERTED TO 12.5 AND PULLED BACK TO 10CMS. THE INFANT WAS EXAMINED AND HAEMODYNAMICALLY STABLE. NO TREATMENT WAS NECESSARY. NO FURTHER OOZE FROM SITE.
Additional Manufacturer Narrative
DURING THE INVESTIGATION, THE REPORTED PROBLEM WAS CONFIRMED. EXAMINATION OF THE DEVICE, A PARTIAL TEAR WAS IDENTIFIED AROUND THE CIRCUMFERENCE OF THE CATHETER AT THE 13MM MARK ON THE CATHETER. THE SURFACES OF THE TEAR WERE NOTED TO BE SMOOTH AND EVEN. FROM PREVIOUS INVESTIGATIONS AND RECREATION TESTING IN THE LABORATORY, WE CAN ADVISE THAT THE SMOOTH ASPECT OF THE TEAR SURFACE IDENTIFIED INDICATES THAT THE UMBILICAL CATHETER HAS COME INTO CONTACT WITH A SHARP INSTRUMENT (FOR EXAMPLE, A SCALPEL BLADE OR SCISSORS), WHICH MAY HAVE OCCURRED DURING INSERTION. ON EVALUATION , WE CAN ADVISE THAT WE HAVE NOT RECEIVED ANY ADDITIONAL REPORTS OF A SIMILAR NATURE FOR THIS LOT NUMBER. THE BATCH REVIEW DOES NOT SHOWN ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICE IS COMPLIANT TO NORM ISO 10555-1. THERE IS A 100% CONTROL OF THE TIGHTNESS OF THE CATHETER PRIOR ITS PACKAGING. FURTHERMORE THE TENSILE STRENGTH IS COMPLIANT. THE MINIMUM MEASURED VALUE IS 17,2N , WHICH IS ABOVE THE MINIMUM ISO VALUE OF 10N. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED DURING OUR INVESTIGATION,THEREFORE NO CORRECTIVE ACTION WILL BE INTIATED AT THIS TIME.
Additional Manufacturer Narrative
THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION. THE BATCH REVIEW DOES NOT SHOWN ANY NON-CONFORMITY. THE PRODUCTS ARE IN CONFORMITY WITH THE SPECIFICATIONS. THE DEVICE IS COMPLIANT TO NORM ISO 10555-1. THERE IS A 100% CONTROL OF THE TIGHTNESS OF THE CATHETER PRIOR ITS PACKAGING. FURTHERMORE THE TENSILE STRENGTH IS COMPLIANT. THE MINIMUM MEASURED VALUE IS 17,2N , WHICH IS ABOVE THE MINIMUM ISO VALUE OF 10N. THERE IS NO OTHER COMPLAINT ON THIS BATCH .
Description of Event or Problem
SPLIT NOTED AT POINT 13. BLOOD OOZING FROM THAT POINT. THE LINE WAS INSERTED (B)(6) 2021 AT 22.00 AND REMOVED ON (B)(6) 2021. LENGTH OF CATHETER INSERTED TO 12.5 AND PULLED BACK TO 10CMS. THE INFANT WAS EXAMINED AND HAEMODYNAMICALLY STABLE. NO TREATMENT WAS NECESSARY. NO FURTHER OOZE FROM SITE.