CENTURION

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, THEY HAVE EXPERIENCED FOUR CASES OF SIGNIFICANT BLEEDING FOLLOWING CIRCUMCISION PROCEDURES. CLINICAL STAFF REPORT THAT THESE DISPOSABLE CLAMPS DO NOT SEEM TO TIGHTEN SUFFICIENTLY, RESULTING IN VISIBLE BLOOD LEAKAGE. OUR PEDIATRICIAN COMPARED THE DISPOSABLE CLAMPS TO OUR NON-DISPOSABLE VERSIONS AND NOTED A SIGNIFICANT DIFFERENCE IN SIZING, WITH THE DISPOSABLES BEING LARGER. ADDITIONALLY, WHEN ATTEMPTING TO TIGHTEN THE DISPOSABLE CLAMP, IT CONTINUES TO SPIN RATHER THAN REACHING A SECURE TENSION LIKE THE NON-DISPOSABLE VERSION. DUE DILIGENCE HAS BEEN COMPLETED. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THE SAMPLE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. IT HAS BEEN DETERMINED THAT THOUGH THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY, RECURRENCE COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.

Description of Event or Problem

ACCORDING TO THE FACILITY, THEY HAVE EXPERIENCED FOUR CASES OF SIGNIFICANT BLEEDING FOLLOWING CIRCUMCISION PROCEDURES.