BEUDAMED
    FDA Adverse Event Summary report: N

    DISPENSER, SOLID MEDICATION

    MDR report key: 8191695 · Received December 20, 2018

    Report

    Report Number
    MW5082524
    Date Received
    December 20, 2018
    Date of Event
    January 25, 2018
    Report Date
    December 20, 2018
    Manufacturer
    UNK
    Product Code
    NXB
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON THE ((B)(6) 2018) ISSUE OF ACUTE CARE ISMP MEDICATION SAFETY ALERT NEWSLETTER, AN ARTICLE APPEARED REGARDING MISSING BARCODES ON CERTAIN PRODUCTS. OUR STAFF HAD IDENTIFIED THE FOLLOWING PRODUCTS THAT ARE MISSING BARCODES ON THE OUTSIDE OF THE IMMEDIATE CONTAINER: GATIFLOXACIN 0.5% OPHTHALMIC SOLUTION 2.5 ML, HITECH, NDC (B)(4); MOVIPREP KIT, SALIX, NDC (B)(4); BIAFINE TOPICAL EMULSION 45 GRAMS, VALEANT, NDC (B)(4); SODIUM CHLORIDE 3% INHALATION SOLUTION 15 ML, MYLAN, NDC (B)(4); HURRICAINE GEL 20% 1 OZ, NDC (B)(4); SPOT ENDOSCOPIC MARKER 5 ML, GI SUPPLY. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: NO; PATIENT COUNSELLING PROVIDED: UNKNOWN; RELEVANT MATERIALS PROVIDED: NONE; SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6), ACCESS NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022533 DISPENSER, SOLID MEDICATION DISPENSER, SOLID MEDICATION NXB UNK
    1022554 DISPENSER, LIQUID MEDICATION DISPENSER, LIQUID MEDICATION KYX UNK
    1022555 DISPENSER, LIQUID MEDICATION DISPENSER, LIQUID MEDICATION KYX UNK
    1022556 DISPENSER, LIQUID MEDICATION DISPENSER, LIQUID MEDICATION KYX UNK
    1022559 DISPENSER, SOLID MEDICATION DISPENSER, SOLID MEDICATION NXB UNK
    1022560 DISPENSER, SOLID MEDICATION DISPENSER, SOLID MEDICATION NXB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1