inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received Jul 22, 2021 · Event occurred Mar 11, 2021

Report 3006260740-2021-02911 · MDR key 12214434

Device

Generic name

Stand, Infusion

Model number

N/A

Catalog number

PIC0220

Lot number

JUEY1044

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) OF JUEY1044 SHOWED SEVEN OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED "CLIPS THAT SECURE CATHETER IN PLACE ARE COMING UNCLIPPED." IT WAS STATED, "THERE WAS NO PATIENT HARM. THE MOVEABLE POSTS WERE INSERTED IN THE WINGS AND THE STATLOCK WAS APPLIED TO THE CHEST AREA, BELOW THE EXIT SITE OF THE CATHETER. NURSES HAVE TAKEN TO TAPING OVED THE GATES TO KEEP IT SECURE."