UMBILICAL CATHETER
Received Jul 21, 2022 · Event occurred Jul 13, 2022
Report 2245270-2022-00065 · MDR key 15077912
Device
Product problems
- Fluid/Blood Leak
- Material Split, Cut or Torn
- Fluid/Blood Leak
- Material Split, Cut or Torn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AT BEGINNING OF SHIFT, UVC INSERTION SITE VISIBLE AT 5.5CM MARK. DURING 0100 ASSESSMENT, UVC SITE WET. TOP DUO-DERM LIFTED OFF OF ABDOMEN. BOTTOM DUO-DERM AND LAYER OF TEGA-DERM STILL INTACT, WITH LINE SPLIT IN TWO PIECES UNDER TEGA-DERM.
Additional Manufacturer Narrative
THE FAILED DEVICE WAS RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.
Additional Manufacturer Narrative
THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN FRANCE FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED ONE SAMPLE FOR INVESTIGATION. ANALYSIS OF THE SAMPLE RECEIVED SHOWS THAT THE CATHETER IS CUT IN TWO PARTS, THE FIRST PART UNDER THE TWO LUMENS MEASURES 14 CM, THE OTHER PART MEASURES 7 CM, PRESENCE OF A SUTURE AT 4 CM FROM THE BLUNT END OF THE CATHETER. THE CUT IS CLEAN, ANGLED AT THE BREAK. IT APPEARS THAT THE CAUSE IS LINKED TO THE USE OF A SHARP OBJECT THERE IS A STATEMENT IN OUR PRODUCT'S IFU: DO NOT APPLY INSTRUMENTS WITH SHARP OR ROUGH EDGES DIRECTLY TO THE CATHETER: EVEN A MINOR CUT COULD TEAR OR BREAK IT. AS THE CATHETER WORKED WELL FOR 11 DAYS, WE DO NOT BELIEVE THIS IS RELATED TO MANUFACTURING DEFECT THEREFORE, NO FURTHER CORRECTIVE ACTION IS INITIATED BY QUALITY MANAGEMENT. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, THIS ISSUE COULD NOT BE TRACED TO MANUFACTURING DEFECT; THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.
Description of Event or Problem
AT BEGINNING OF SHIFT, UVC INSERTION SITE VISIBLE AT 5.5CM MARK. DURING 0100 ASSESSMENT, UVC SITE WET. TOP DUO-DERM LIFTED OFF OF ABDOMEN. BOTTOM DUO-DERM AND LAYER OF TEGA-DERM STILL INTACT, WITH LINE SPLIT IN TWO PIECES UNDER TEGA-DERM.