inforMED
MalfunctionFOX

STATLOCK PICC PLUS CRESCENT SLIDING POST

Received May 14, 2021 · Event occurred Apr 21, 2021

Report 3006260740-2021-01855 · MDR key 11824969

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Product code (FOX)
Model (UNK)

Device

Generic name

Stand, Infusion

Model number

UNK

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. THE COMPLAINTS FOR THIS LOT NUMBER (JUEY1044) HAVE BEEN REPORTED FROM THE SAME FACILITY.

Description of Event or Problem

IT WAS REPORTED CLIPS THAT SECURE CATHETER IN PLACE ARE COMING UNCLIPPED. NO OTHER INFORMATION WAS PROVIDED.