inforMED
MalfunctionFOX

STATLOCK

Received Sep 20, 2022 · Event occurred Aug 24, 2022

Report 15454547 · MDR key 15454547

Device

Generic name

Stand, Infusion

Catalog number

VPPDFP

Lot number

JUGR1460

Product problems

  • Break
  • Mechanical Problem

Patient

12045 DA · Female

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

Narrative

Description of Event or Problem

DURING PICC DRESSING CHANGE, EXPERIENCED A FAULTY STATLOCK (PIECE OF STATLOCK PLASTIC BROKE OFF, AND CLASP OF THE STATLOCK WAS UNABLE TO CLOSE). PICC LINE WAS HEAVILY MANIPULATED DUE TO FAULTY STATLOCK. FAULTY STATLOCK WAS REMOVED AND PICC RECLEANED. NEW STATLOCK PLACED W/O ISSUE, DRESSING CHANGE COMPLETED W/O ISSUE. X-RAY WAS COMPLETED TO CONFIRM LINE PLACEMENT PRIOR TO LINE USE. OK TO USE ORDER GIVEN BY CRNP PRIOR TO PICC USE. STATLOCK REF VPPDFP, STATLOCK LOT JUGR1460, USE BY DATE 2025-04-28.