3.5FR URETHANE UMB CATH
Received Sep 15, 2021 · Event occurred Aug 1, 2021
Report 3009211636-2021-00765 · MDR key 12474739
Device
Generic name
Catheter, Umbilical Artery
Model number
8888160333Catalog number
8888160333
Lot number
2007100042
Product problems
- Break
- Break
Patient
3 DA
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.
Description of Event or Problem
THE CUSTOMER STATED THAT DURING THE REMOVAL OF THE UVC, THE UVC BROKE 1.5CM ABOVE THE INSERTION SITE. THE CATHETER LINE WAS HELD IN PLACE UNTIL THE PROVIDER ARRIVED. THE ENTIRE REMAINING LENGTH WAS REMOVED WITH A HEMOSTAT. BLOOD LOSS WAS MINIMAL.