BEUDAMED
    FDA Adverse Event Summary report: N

    21G NEEDLE

    MDR report key: 16627191 · Received March 27, 2023

    Report

    Report Number
    MW5116000
    Date Received
    March 27, 2023
    Manufacturer
    UNK
    Product Code
    FMI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE HAD MULTIPLE EVENT REPORTS OF PHARMACISTS NOTING PARTICULATE IN DAPTOMYCIN PREPARATIONS WITH THE DAPTOMYCIN FOR INJECTION 500MG/VIAL XELLIA PHARMACEUTICALS NDC 70594-034-1 PRODUCT. WITH FURTHER INVESTIGATION, IT APPEARS THIS WAS NOT LIMITED TO A CERTAIN INDIVIDUAL WHO WAS COMPOUNDING AND OCCURRED MULTIPLE DATES AND TIMES WITH, VARIOUS LOT NUMBERS AT DIFFERENT SITES ACROSS OUR HEALTH SYSTEM. THE MANUFACTURE NOTES NEED TO USE CERTAIN PRODUCTS TO COMPOUND THIS PRODUCT INCLUDING A 21G NEEDLE (WHICH IS SMALLER THAN STANDARD NEEDLES USED FOR COMPOUNDING OR A VENTED NEEDLE FROM BBRAUN (REF 415072). OUR SITE HAS USED BOTH DEVICES A 21G NEEDLE AND THE VENTED NEEDLE RECOMMENDED BY THE MANUFACTURE WITH CONTINUED CONCERNS OF CORING REPORTED VISIBLE TO THE EYE. LUCKILY THESE HAVE BEEN NEAR MISS EVENTS CAUGHT BY OUR PHARMACIST PRIOR TO REACHING THE PATIENTS WITH NO HARM NOTED TO PATIENTS, HOWEVER, IS STILL OF CONCERN. WE HAVE ALERTED THE MANUFACTURE AND THEY NOTED THEY DID NOT FIND ANY INTERNAL ISSUES WITH THE PRODUCT GIVEN THE CONSISTENT CONCERNS WE NOW HAVE THE TECHNICIANS FILTER THIS PRODUCT AT OUR SITE PRIOR TO DISPENSING. (B)(4), SUBMISSION ID: 84673. REF REPORT: MW5115999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480430 21G NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DAPTOMYCIN XELLIA, 70594-034-01, PHARMACEUTICALS, INC., 500MG/10ML | SODIUM CHLORIDE 0.9% FLUSH 10 ML, HOSPIRA INC. SINGLE-DOSE VIAL