DEROYAL UMBILICAL CORD, CLAMP
Received Jan 7, 2022 · Event occurred Dec 3, 2021
Report 1057404-2021-00003 · MDR key 13192935
Device
Generic name
Device, Occlusion, Umbilical
Manufacturer
Deroyal Industries, Inc.Model number
10-1281Catalog number
10-1281
Product problems
- Product Quality Problem
- Product Quality Problem
Patient
1 DA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE UMBILICAL CLAMP OPENED AFTER THE INFANT ARRIVED AT THE NURSERY. NO HARM WAS CAUSED TO THE INFANT AND THE CLAMP WAS DISCARDED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORDS FOR THIS LOT, INCLUDING THE PERFORMANCE TEST RECORDS, FOUND NO ISSUES. ALL PERFORMANCE TESTING PASSED. THE MATERIAL CERTIFICATIONS WERE REVIEWED AND FOUND TO BE ACCEPTABLE AND WITHIN REQUIRED SPECIFICATION. A REPRESENTATIVE SAMPLE OF SAME UMBILICAL CORD CLAMP WAS SUBMITTED FOR EVALUATION. THERE WERE NO FINDINGS AS DEVICE MEETS CURRENT REQUIRED SPECIFICATION. THE ROOT CAUSE IS UNDERMINED AT THIS TIME. THERE ARE NO PLANNED CORRECTIVE ACTIONS. THE SALES TO COMPLAINT FEEDBACK RATIO IS FOUND TO BE 0.092% FOR LAST 24 MONTHS OF SHIPMENTS. COMPLAINT REPORTS ARE TRENDED AND MANAGED THROUGH CORRECTIVE AND PREVENTIVE ACTION SYSTEM. IF MORE INFORMATION BECOMES AVAILABLE, THIS COMPLAINT INVESTIGATION WILL BE REOPENED AND FOLLOW UP SUBMITTED. AS OF TODAY, THIS COMPLAINT INVESTIGATION IS CONSIDERED CLOSED.