CLAMP,UMBILICAL CORD,PLASTIC,OFF-WHITE
Received Jul 12, 2023 · Event occurred May 30, 2023
Report 1417592-2023-00286 · MDR key 17309401
Device
Generic name
Clamp,umbilical Cord,plastic,off-white
Manufacturer
Medline Industries LpCatalog number
DYNJ04220
Product problems
- Decrease in Pressure
- Decrease in Pressure
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER ON (B)(6) 2023, AFTER BEING IN PLACE FOR A FEW HOURS, BLEEDING WAS NOTED. THE CUSTOMER REPORTED THIS WAS DUE TO THE CLAMP NOT BEING TIGHT ENOUGH. DUE TO THIS, THE PROVIDER WAS NOTIFIED AND A NEW DEVICE WAS USED. THE CUSTOMER REPORTED THIS WAS CAUGHT EARLY AND REPORTED NO ADDITIONAL INTERVENTION OR INJURY RELATED TO THE INCIDENT. THE DEVICE WAS DISCARDED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
CLAMPS NOT TIGHT ENOUGH CAUSING BLEEDING.