KIT, INFANT MATERNITY
Received Aug 23, 2024 · Event occurred Jul 20, 2024
Report 3015173212-2024-00003 · MDR key 20054229
Device
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
0 DA · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE CLAMP "POPPED OPEN LEAVING THE FRESH ARTERIES AND VEINS IN THE UMBILICAL CORD OPEN AND BLEEDING".
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 THE CLAMP "POPPED OPEN LEAVING THE FRESH ARTERIES AND VEINS IN THE UMBILICAL CORD OPEN AND BLEEDING". THE CUSTOMER REPORTED AFTER THE INCIDENT OCCURRED A NEW CLAMP WAS PLACED, AND MONITORING OF THE PATIENT WAS INCREASED. THE CUSTOMER REPORTED THE MOTHER WAS "SPRAYED WITH BLOOD". THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE REQUIRED AS A RESULT OF THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.