inforMED
MalfunctionFOX

STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PD, PIGTAIL PD, 25

Received Apr 26, 2021 · Event occurred Mar 3, 2021

Report 3006260740-2021-01544 · MDR key 11727074

Device

Generic name

Stand, Infusion

Model number

NA

Catalog number

CV0220CE

Lot number

JUFN1795

Product problems

  • Misconnection
  • Misconnection

Patient

48 YR

  • 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 JUFN1795 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PICC CATHETER MAINTENANCE. WHEN USING THE CATHETER HOLDER, IT WAS FOUND THAT THE BUCKLE WAS NOT TIGHT, AND THE CATHETER HOLDER WAS REPLACED WITHOUT ADVERSE CONSEQUENCES.