FDA Adverse Event Malfunction Summary report: N

SIROS DELIVERY SET

MDR report key: 22873536 · Received August 22, 2025

Report

Report Number: 3005579300-2025-00014
Event Type: Malfunction
Date Received: August 22, 2025
Date of Event: July 10, 2024
Report Date: August 22, 2025
Manufacturer: SIRTEX MEDICAL PTY LIMITED
Product Code: IWJ
UDI-DI: 00850014612023
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE EVENT INVOLVED NO THREAT TO PUBLIC HEALTH AND NO DEATH OR SERIOUS INJURY TO THE PATIENT. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY DUE TO THE POTENTIAL OF RADIOACTIVE CONTAMINATION OR SHOULD THE FULL DOSE NOT BE ABLE TO BE ADMINISTERED TO THE PATIENT. A BATCH RECORD REVIEW WAS PERFORMED AND DID NOT DISPLAY ANYTHING ABNORMAL FOR THE MANUFACTURING PROCESS.

Description of Event or Problem · 0

DOCTOR HAD ALREADY DELIVERED 20 ML OF D5W THROUGH THE D-LINE TO THE PATIENT. THE DOCTOR ATTACHED ANOTHER FULL 20 ML SYRINGE OF D5W TO THE D-LINE (TO FULLY DELIVER MICROSPHERES) AND WITH HIS FIRST ALIQUOT THE D-LINE SYRINGE CONNECTOR BROKE OFF (WITH THE SYRINGE STILL ATTACHED) FROM THE MAIN D-LINE. NUCLEAR MEDICINE WAS THEN BROUGHT INTO SURVEY POTENTIAL CONTAMINATION. IT WAS CONFIRMED WITH THERE BEING NO RADIOACTIVITY ON THE "CONTAMINATED" TOWELS (AND FURTHER CONFIRMED ON IMMEDIATE CLEANUP POST-DELIVERY SURVEYS AND POST MEASUREMENT READINGS). AFTER CONFIRMING SAFETY OF THE ENVIRONMENT, THE DOCTOR SIMPLY RE-ATTACHED THE D-LINE SYRINGE CONNECTOR (WITH SYRINGE STILL ATTACHED) TO THE D-LINE TUBING AND CAREFULLY DELIVERED ANOTHER 20 ML OF D5W WITH NO COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2618804	SIROS DELIVERY SET	System, applicator, radionuclide, manual	IWJ	SIRTEX MEDICAL PTY LIMITED	SIR-10300	1126415	00850014612023

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown