inforMED
MalfunctionMSD

HEMOSPLIT DIALYSIS

Received Apr 21, 2026 · Event occurred Mar 27, 2026

Report 3006260740-2026-02684 · MDR key 24936994

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Product code (MSD)
Model (UNKNOWN HEMOSPLIT DIALYSIS)

Device

Generic name

Dialysis Catheter

Catalog number

UNKNOWN HEMOSPLIT DIALYSIS

Lot number

UNKNOWN

Product problems

  • Fracture

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A DIALYSIS CATHETER PLACEMENT PROCEDURE USING THE HEMOSPLIT DIALYSIS CATHETER. POST THE PROCEDURE, THE TUNNELER ON THE HEMOSPLIT DEVICE BROKE. THERE WAS NO REPORTED PATIENT INJURY.