BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HEPARIN LOCK FLUSH 500 UNITS/5ML SYRINGES

    MDR report key: 15237408 · Received August 16, 2022

    Report

    Report Number
    1423982-2022-00005
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    May 25, 2022
    Report Date
    July 7, 2022
    Manufacturer
    MEDEFIL, INC.
    Product Code
    NZW
    UDI-DI
    6425333335
    PMA / PMN Number
    K092491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE EVALUATION, WE FOUND THAT BOTH PRODUCTS ARE DIFFERENT FROM EACH OTHER. HEPARIN LOCK FLUSH LABEL IS PREDOMINANTLY YELLOW IN COLOR WHEREAS THE SODIUM CHLORIDE INJECTION, USP, 0.9% LABEL IS PREDOMINANTLY PEACH IN COLOR. THE TIP CAP COLORS OF THE PRODUCTS ARE DIFFERENT - YELLOW FOR HEPARIN LOCK FLUSH AND PEACH FOR SODIUM CHLORIDE INJECTION, USP 0.9%. THE PLASTIC POUCH CONTAINING THE SYRINGES ARE ALSO DIFFERENT FOR BOTH THE PRODUCTS. HEPARIN LOCK FLUSH SYRINGE IS IN A CLEAR PLASTIC POUCH WITH IMPRINT "DO NOT PLACE THE SYRINGE ON THE STERILE FIELD" PRINTED ON IT, WHEREAS, SODIUM CHLORIDE INJECTION, USP, 0.9% IS IN A CLEAR PLASTIC POUCH. BASED ON THE DIFFERENCES NOTED ABOVE, BOTH PRODUCTS CAN BE EASILY DIFFERENTIATED FROM EACH OTHER. BASED ON THE RECOMMENDATION OF HEALTH CARE PROFESSIONS, MEDEFIL HAS FILED A SUPPLEMENT CBE-0 (NDA 202832, S-006, ECTD SEQ. 0022, FILED ON (B)(6) 2022) TO CHANGE THE COLOR OF SYRINGE AND DISPENSER BOX LABELS FROM PEACH TO GREY.

    Description of Event or Problem · 0

    ON (B)(6) 2022, MEDEFIL INC. RECEIVED EMAIL FROM THE FDA REGARDING MDR REPORT# (B)(4). IT WAS MENTIONED IN THE MDR THAT SALINE FLUSHES AND HEPARIN FLUSHES PROVIDED BY MEDEFIL, INC. ARE SIMILAR IN COLOR. DUE TO DRUG SHORTAGES WE HAVE BEEN HAVING TO PURCHASE WHAT WE CAN GET MATERIALS FILLS THE SALINE. THE HEPARIN IS A GOLD COLOR AND THE SALINE IS PEACH. HEPARIN WAS PUT INTO THE SALINE BIN IN THE SUPPLY ROOM. A SEASONED NURSE CAUGHT THIS BUT THEY VERY MUCH LOOK ALIKE. THE SUPPLY CHAIN ISSUES ARE ABSOLUTELY MAKING THINGS EXTREMELY DIFFICULT. EDUCATION TO PAY EXTRA ATTENTION TO HOW THINGS ARE LABELED. ALERT TO ALL STOCK WHO STAFF AND ADMINISTER MANUFACTURER/LABELER SIMILAR LABEL/PACKAGING. ERROR OCCURRED; MEDICATION DID NOT REACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012289 HEPARIN LOCK FLUSH 500 UNITS/5ML SYRINGES HEPARIN, VASCULAR ACCESS FLUSH NZW MEDEFIL, INC. N/A N/A 6425333335

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown