MalfunctionIQG

ENOXAPARIN SODIUM INFECTION

Received Jul 11, 2024 · Event occurred Jun 6, 2024

Report 19719507 · MDR key 19719507

Device

Generic name

Adaptor, Holder, Syringe

Manufacturer

Fresenius Kabi Usa, Llc

Model number

NDC 63323-564-63

Catalog number

PSFIL-011379-02

Lot number

A0180026

Patient

60 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

RN DELIVERED DOSE OF LOVENOX AS ORDERED AND THEN ACTIVATED SAFETY WHEN A SMALL PIECE BROKE OFF CAUSING THE DEVICE TO NOT KEEP THE NEEDLE IN THE SAFETY AREA. MANUFACTURER RESPONSE FOR ENOXAPARIN SODIUM INJECTION 40MG, ENOXAPARIN SODIUM INFECTION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED ON 6/25/24 TO CUSTOMERSERVICE.USA@FRESENIUS-KABI.COM. EQUIPMENT IS AVAILABLE FOR RETURN TO MANUFACTURER FOR INVESTIGATION WITH MAILING LABELS PROVIDED.