inforMED
MalfunctionFOX

STATLOCK SLIDING POST CRESCENT PAD SKIN PREP

Received May 6, 2021 · Event occurred Apr 5, 2021

Report 3006260740-2021-01729 · MDR key 11787817

Device

Generic name

Stand, Infusion

Catalog number

CV0220CE

Lot number

JUEQ2360

Product problems

  • Material Deformation
  • Material Deformation

Patient

70 YR

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEQ2360 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED WHEN THE PATIENT REPLACED THE CATHETER FIXATOR ON (B)(6) 2021, THE BUCKLE BROKE AND THE CATHETER COULD NOT BE FIXED. REPLACE THE FIXATOR IMMEDIATELY AFTER DISCOVERY, SO THAT THE CATHETER CAN BE USED NORMALLY. NO OTHER INFORMATION WAS PROVIDED.