inforMED
MalfunctionFOX

STATLOCK CV PLUS SLIDING POST

Received Jan 14, 2021 · Event occurred Dec 8, 2020

Report 3006260740-2020-21319 · MDR key 11172057

Device

Generic name

Stand, Infusion

Model number

N/A

Catalog number

CV0220CE

Lot number

JUDPF189

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUDPF189 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. DEVICE NOT RETURNED FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH AN INTRAPULMONARY INFECTION AND THE CONDITION WAS SEVERE. MEDICAL STAFF GAVE THE IMPLANTED VENOUS INDWELLING NEEDLE ACCORDING TO THE NORMAL OPERATION. DURING THE NORMAL INFUSION PROCESS, FLUID LEAKAGE OCCURRED AT THE TAIL OF THE INDWELLING NEEDLE.