inforMED
MalfunctionFOX

STATLOCK CV PLUS SLIDING POST

Received May 26, 2021 · Event occurred May 4, 2021

Report 3006260740-2021-02048 · MDR key 11890309

Device

Generic name

Stand, Infusion

Model number

N/A

Catalog number

CV0226CE

Lot number

UNKNOWN

Product problems

  • Misconnection
  • Misconnection

Patient

Not reported

  • 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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

Description of Event or Problem

IT WAS REPORTED THAT IN THE LAST WEEKS THE FACILITY HAS SEEN SEVERAL STATLOCK WITH A WEAK LOCK. IT HAS BROKEN IN ONE OF THE SIDES. IT IS UNKNOWN THE NUMBER OF DEVICES USED.