inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received Apr 23, 2021 · Event occurred Mar 31, 2021

Report 3006260740-2021-01483 · MDR key 11713588

Device

Generic name

Stand, Infusion

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 ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT ONE WING OF THE STATLOCK DEVICE DOES NOT STAY CLOSED. NO OTHER INFORMATION WAS PROVIDED.