inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received May 13, 2021 · Event occurred Apr 21, 2021

Report 3006260740-2021-01846 · MDR key 11822773

Device

Generic name

Stand, Infusion

Model number

N/A

Catalog number

PIC0220

Lot number

UNK

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 CLIPS THAT SECURE CATHETER IN PLACE ARE COMING UNCLIPPED. ADDITIONAL INFO. RECEIVED 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. I STILL DON¿T HAVE A SAMPLE OF THE AFFECTED PRODUCT TO SEND YOU."