inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received May 13, 2021 · Event occurred Mar 12, 2021

Report 3006260740-2021-01844 · MDR key 11822612

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 FIVE 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. ADD INFO RCVD 04/26/2021 - THERE WAS NO PATIENT HARM WITH ANY OF THE COMPLAINTS. THE PLACEMENT WAS EXACTLY THE SAME FOR ALL PATIENTS. THE MOVEABLE POSTS WERE INSERTED IN THE WINGS AND THE STATLOCK WAS APPLIED TO THE CHEST AREA, BELOW THE EXIT SITE OF THE CATHETER. THIS STATLOCK HAS BEEN USED FOR YEARS IN THIS WAY AND NEVER HAVE THE GATES POPPED OPEN AS THEY DO NOW. NURSES HAVE TAKEN TO TAPING OVED THE GATES TO KEEP IT SECURE.