MANIFOLD 2 PORT RIGHT HAND, ROTATING ADAPTOR OFF
Received Apr 9, 2026 · Event occurred Apr 8, 2026
Report 3004605321-2026-00001 · MDR key 24835214
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Deroyal Intercontinental, S.r.lModel number
60-2225Lot number
62722578
Product problems
- Crack
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A USER FACILITY REPORTED, "WE HAD AN ISSUE WITH A MANIFOLD LEAKING. IT APPEARS THAT THERE IS A CRACK IN IT. I AM NOT SURE IF IT WAS THERE OR HAPPENED WHEN WE CONNECTED IT. INCIDENT HAPPENED DURING USE IN A PROCEDURE PERFORMED IN IRELAND."
Additional Manufacturer Narrative
A USER FACILITY REPORTED, "WE HAD AN ISSUE WITH A MANIFOLD LEAKING. IT APPEARS THAT THERE IS A CRACK IN IT. I AM NOT SURE IF IT WAS THERE OR HAPPENED WHEN WE CONNECTED IT. INCIDENT HAPPENED DURING USE IN A PROCEDURE PERFORMED IN IRELAND." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE; HOWEVER, IT HAS NOT YET BEEN RECEIVED. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.