Spinning Spiros® Closed Male Luer, Red Cap
Received Jul 27, 2026 · Event occurred Jul 1, 2026
Report 9617594-2026-00925 · MDR key 50011434
Device
Generic name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Manufacturer
Icu Medical De Mexico, S. De R.l. De C.v.Catalog number
CH2000S-C
Product problems
- Disconnection
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A reported incident involving a Spinning Spiros Closed Male Luer, Red Cap, Spiros connector failed during a Blincyto (blinatumomab) infusion. The Spiros was observed to have become disconnected from the tubing connection site. The patient's caregiver reported that the connector "fell off." Attempts by the nurse to reconnect the Spiros were unsuccessful, as the connector continued to rotate and would not attach to the tubing luer lock. The event occurred during therapy. There were no reported patient involvement and no injury or adverse event reported.
Additional Manufacturer Narrative
Device has not been returned to Manufacturer. A supplemental MDR will be filed when additional information becomes available.