CLAMP,UMBILICAL CORD,PLASTIC,OFF-WHITE
Received Jul 13, 2023 · Event occurred Jun 16, 2023
Report 1417592-2023-00290 · MDR key 17317710
Device
Generic name
Clamp,umbilical Cord,plastic,off-white
Manufacturer
Medline Industries LpCatalog number
DYNJ04220
Lot number
41223040008
Product problems
- Decrease in Pressure
- Decrease in Pressure
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED "UMBILICAL CORD CLAMPS NOT SEALING PROPERLY CAUSING BLOOD TO LEAK OUT'. NO ADDITIONAL DETAILS WERE PROVIDED. A SAMPLE WAS REQUESTED TO BE RETURNED FOR EVALUATION. 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
"UMBILICAL CORD CLAMPS NOT SEALING PROPERLY CAUSING BLOOD TO LEAK OUT".