CLAMP UMBILICAL CORD

Description of Event or Problem

THE UMBILICAL CORD CLAMPS THAT ARE IN OUR VAGINAL PACKS ARE HARD TO CLAMP AND WHEN IT CLAMPS IT COMES OFF EASILY. UNFORTUNATELY, THIS WAS NOT REPORTED ASAP UNTIL AN INCIDENT HAPPENED. IT CAME OFF FROM A NEWLY BORN BABY AND BABY LOST SOME BLOOD.

Additional Manufacturer Narrative

A USER FACILITY COMPLAINT WAS RECEIVED ON 2/9/2023, REPORTING, "THE UMBILICAL CORD CLAMPS THAT ARE IN OUR VAGINAL PACKS ARE HARD TO CLAMP AND WHEN IT CLAMPS IT COMES OFF EASILY. UNFORTUNATELY, THIS WAS NOT REPORTED ASAP UNTIL AN INCIDENT HAPPENED. IT CAME OFF FROM A NEWLY BORN BABY AND BABY LOST SOME BLOOD." THE SAMPLE IS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE MORE INFORMATION IS CONCLUDED FROM THE INVESTIGATION.

Additional Manufacturer Narrative

THE SAMPLE NOR A PICTURE OF THE SAMPLE WAS NOT AVAILABLE FOR RETURN TO DEROYAL FOR EVALUATION. ROOT CAUSE: WITHOUT A DEFECTIVE SAMPLE, THE ROOT CAUSE COULD NOT BE ESTABLISHED. POTENTIAL ROOT CAUSE: TWO POTENTIAL ROOT CAUSES THAT COULD NOT BE RULED OUT WERE THAT THE PART MAY NOT HAVE BEEN COMPLETELY FORMED IN MANUFACTURING OR THERE COULD HAVE BEEN A USE ERROR IN APPLICATION BY THE USER. PRODUCTION RECORDS WERE REVIEWED, AND NO ISSUES WERE FOUND. BOTH WORK ORDERS AND THE FAILURE MODES AND EFFECTS ANALYSIS (FMEA) WERE REVIEWED AND NO ISSUES WERE FOUND WITH EITHER. AN INVENTORY CHECK OF THE UMBILICAL CLAMPS WAS MADE BY DEROYAL. A TOTAL OF 50 OF THE 10-1281 CLAMPS WERE INSPECTED AND NO DISCREPANCIES WERE IDENTIFIED DURING THE INSPECTION. BECAUSE NO ROOT CAUSE COULD BE ESTABLISHED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.