inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received May 12, 2021 · Event occurred Apr 21, 2021

Report 3006260740-2021-01798 · MDR key 11813421

Device

Generic name

Stand, Infusion

Catalog number

PIC0220

Lot number

JUEW3276

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 JUEW3276 SHOWED SEVEN OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT SEVEN STATLOCK SECUREMENT CLIPS DIDN'T CLOSE PROPERLY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES THE SEVENTH OF SEVEN DEVICES.