SIROS D-VIAL PREP SET
Received Jan 9, 2026 · Event occurred Dec 11, 2025
Report 3009088444-2026-00001 · MDR key 24022841
Device
Generic name
System, Applicator, Radionuclide, Manual
Manufacturer
Sirtex Medical, Inc.Model number
SIR-10200Lot number
1142842
Product problems
- Emergency Power Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE DOSE DELIVERY, A LEAK WAS OBSERVED FROM THE D-VIAL. THREE ALIQUOTS OF THE DOSE WERE ATTEMPTED AND THE PATIENT RECEIVED ~65% OF THE DOSE. THE LEAK WAS CONTAINED WITHIN THE D-VIAL HOLDER AND NO CONTAMINATION OCCURRED. THE PHARMACY WAS CALLED AND PROVIDED A SECOND DOSE AND THE SECOND DELIVERY WAS ACHIEVED WITH NO FURTHER INCIDENT.
Additional Manufacturer Narrative
THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.
Additional Manufacturer Narrative
THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT AND THEY RECEIVED THEIR DOSE. SIRTEX HAS LEARNED THAT A NEW D-VIAL WAS USED FOR THE DELIVERY OF THE SECOND PREPARED DOSE. THIS MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED TO THE PATIENT. A REVIEW OF PRODUCTION RECORDS SHOW THE BATCH WAS MANUFACTURED TO APPROVED SPECIFICATIONS AND MET ALL QUALITY ASSURANCE CRITERIA. EACH UNIT IS SUBJECT TO A 100% LEAK TEST INSPECTION PER THE SUPPLIER'S PROCEDURE. THE DEVICE WAS RETURNED AND FUNCTIONALLY TESTED BY SIRTEX. THE EVENT WAS NOT REPLICATED AS NO LEAK WAS OBSERVED. SIRTEX MEDICAL AFFAIRS HAS ALSO STATED FROM A MEDICAL PERSPECTIVE, THIS EVENT DOES NOT REPRESENT A PATIENT ADVERSE EVENT BUT RATHER A DEVICE-RELATED MALFUNCTION WITHOUT PATIENT HARM. THE TEMPORARY UNDER-DELIVERY OF DOSE WAS PROMPTLY RECOGNIZED AND MITIGATED, AND THERE IS NO INDICATION OF INCREASED SAFETY RISK OR NEGATIVE IMPACT ON PATIENT OUTCOME. THE OVERALL BENEFIT/RISK PROFILE REMAINS FAVORABLE, AND NO ADDITIONAL PATIENT-LEVEL MEDICAL INTERVENTION OR FOLLOW-UP IS WARRANTED BASED ON THE INFORMATION AVAILABLE.
Description of Event or Problem
DURING THE DOSE DELIVERY, A LEAK WAS OBSERVED FROM THE D-VIAL. THREE ALIQUOTS OF THE DOSE WERE ATTEMPTED AND THE PATIENT RECEIVED ~65% OF THE DOSE. THE LEAK WAS CONTAINED WITHIN THE D-VIAL HOLDER AND NO CONTAMINATION OCCURRED. THE PHARMACY WAS CALLED AND PROVIDED A SECOND DOSE AND THE SECOND DELIVERY WAS ACHIEVED WITH NO FURTHER INCIDENT.