inforMED
MalfunctionFOD

UMBILICAL CORD CLAMP, 100/CS, UMBILICAL CORD CLAMP, 100/CS

Received Aug 9, 2024 · Event occurred Sep 20, 2023

Report 3004605321-2023-00004 · MDR key 19950661

Device

Generic name

Device, Occlusion, Umbilical

Model number

6833

Lot number

59423471

Product problems

  • Positioning Failure
  • Positioning Failure

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "WHEN OUR NICU RESPONDER WAS WITH A NEW PATIENT PLACING A CORD CLAMP, SHE WAS UNABLE TO GET IT TO STAY LOCKED AND THE CLAMP CONTINUED TO BOUNCE OPEN." DEROYAL INDUSTRIES HAS REQUESTED THAT THE SAMPLE BE RETURNED. 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 BECOMES AVAILABLE.

Description of Event or Problem

A USER FACILITY REPORTED, "WHEN OUR NICU RESPONDER WAS WITH A NEW PATIENT PLACING A CORD CLAMP, SHE WAS UNABLE TO GET IT TO STAY LOCKED AND THE CLAMP CONTINUED TO BOUNCE OPEN."

Additional Manufacturer Narrative

A USER FACILITY REPORTED, "WHEN OUR NICU RESPONDER WAS WITH A NEW PATIENT PLACING A CORD CLAMP, SHE WAS UNABLE TO GET IT TO STAY LOCKED AND THE CLAMP CONTINUED TO BOUNCE OPEN." THE SAMPLE, AND OTHERS FROM THE SAME LOT, WERE RETURNED TO DEROYAL. EACH OF THE SAMPLES WERE REVIEWED FOR DEFORMITIES FROM MOLDING, BUT NO DEFORMITIES WERE IDENTIFIED. EACH SAMPLE WAS ALSO APPLIED TO TUBING. ALL DEVICES SNAPPED CLOSED AND DID NOT POP OPEN. PRODUCTION RECORDS WERE REVIEWED FOR THE LOTS RETURNED, AND NO MANUFACTURING ISSUES COULD BE IDENTIFIED. PRESSURE TESTS THAT ARE CONDUCTED AT THE END OF PRODUCTION TO ENSURE EACH SAMPLE CLOSES WITH THE PROPER AMOUNT OF PRESSURE WERE REVIEWED. EACH SAMPLE WAS WITHIN THE ACCEPTABLE RANGE. SHIPPING, PACKAGING, AND STORAGE ERRORS WERE ALSO RULED OUT BASED ON OBSERVATIONS AND TESTING. A COMPLAINT TO SALES RATIO WAS CONDUCTED FOR THE PAST TWO YEARS AND WAS FOUND TO BE (B)(4). ROOT CAUSE: BASED ON TESTING AND PRODUCTION RECORD REVIEWS, THE PROBLEM COULD NOT BE REPRODUCED OR IDENTIFIED. BECAUSE OF THIS, NO ROOT CAUSE COULD BE ESTABLISHED. CORRECTIVE AND PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE COULD BE ESTABLISHED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS SURROUNDING THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.